Wednesday, September 26, 2018

Automated External Defibrillation Program

Automated External Defibrillation (AED) Program

 

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 (February 2018) HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure

AUDIENCE: Emergency Medicine, Risk Manager, Nursing
 
ISSUE: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.
As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device's Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.
However, the HeartStart MRx will continue to work in "Manual" mode after AED mode failure, though the electrocardiogram (EKG) displayed on the device will be noisy, which may make provider interpretation difficult.
 
  • Model/Item Numbers: M3535A, M3536A
  • Lot Numbers: See "Full List of Affected Devices
  • Manufacturing Dates: September 22, 2016 to October 31, 2016
  • Distribution Dates: September 26, 2016 to November 2, 2016
BACKGROUND: The HeartStart MRx Monitor/Defibrillator is intended for use by or on the order of a physician, and should only be administered by medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.
RECOMMENDATION: On June 13, 2017, Philips Electronics sent affected customers a "Medical Device Correction Notification" informing them of the device's risks. In the letter, Philips directed customers to:
  • Check all inventory for affected models of the HeartStart MRx Defibrillator.
  • Contact Philips if the HeartStart MRx Defibrillator fails to function as intended. If the device fails to function, users:
    • Should switch the device to manual mode (if previously operating in AED mode).
    • May still use the EKG display and waveforms from other monitoring leads to identify a shockable rhythm and deliver shock therapy while in manual mode.
    • May notice the device indicates poor pad placement even though the pads are appropriately positioned.
    • Will be contacted by Philips to repair the affected device(s) once replacement parts are available.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the FDA recall notice, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm596134.htm

 

(October 2017) Physio-Control Launches Voluntary Field Action for Specific Production Lots of Infant/Child Reduced Energy Defibrillation Electrodes Produced by Cardinal Health

Physio-Control announced today that the company is launching a voluntary field action for specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health.

The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.

The defibrillation electrodes are used only with LIFEPAK EXPRESS® AED, LIFEPAK CR® Plus AED, LIFEPAK® 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Adult defibrillation electrodes are not impacted. Approximately 14,200 electrodes have been affected. There have been no customer complaints reported for this issue.

The company is contacting customers to notify them of the issue, and to provide customers with correct electrode placement instructions to be included with the AEDs until they receive their corrected defibrillation electrodes. Physio-Control will provide replacement products for all unused affected defibrillation electrodes.

As an alternative, if customers decide not to use the affected defibrillation electrodes and they do not have a spare set of infant/child defibrillation electrodes, based on American Heart Association (AHA) and European Resuscitation Council (ERC) 2015 Guidelines, 1,2 customers may consider the use of adult defibrillation electrodes until they receive their replacement set of infant/child defibrillation electrodes.

Affected customers will be notified by letter. Information about this notice is available at: https://www.physio-control.com/ProductNotices.aspx. Customers with questions regarding this notification, please contact Physio-Control by calling 1-866-231-1220, 6:00 a.m. to 4:00 p.m. (Pacific) Monday – Friday, or by email to rsrecalls@physio-control.com or fax to 1-866-448-9567.

In addition to contacting Physio-Control, any potential quality problems or adverse reactions or events associated with the use of a Physio-Control product may be reported to the U.S. Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm, by phone 1-800-332-1088 or fax 1-800-FDA-0178.

1 Atkins D, Berger S, Duff J, et al. American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Care. Circulation. Part 11: Pediatric Basic Life Support and Cardiopulmonary Resuscitation Quality. 2015;132(18 suppl 2): pS525.

2 Ian K. Maconochie, Robert Bingham et al. European Resuscitation Council Guidelines for Resuscitation 2015 Section 6. Pediatric life support. Resuscitation 95 (2015) 223–248: p235.

 

(December 2013) HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock

AUDIENCE: Risk Manager, Emergency Medicine, Health Professional

ISSUE: FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare. Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation.  These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.

BACKGROUND: An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly.

In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock.

In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.

RECOMMENDATION: All owners of the Philips HeartStart AEDs should contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm Pacific Time. All owners should keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. If unsure if Philips HeartStart AED is affected by this recall or you received a replacement unit after the September 2012 recall notification, please contact Philips Healthcare for additional information. Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing “i-button” if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock. For additional information, please refer to the safety communication.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

(May 2011) Defibtech Announces a Voluntary Recall of DDU-100 series AEDs Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier.

http://www.fda.gov/Safety/Recalls/ucm253582.htm

 

 

Cardiac Science AED Recall ~ The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models:

 

o    Powerheart 9300A, 9300E, 9300P, 9390A, 9390E

o    CardioVive 92532 

o    CardioLife 9200G and 9231 

Customers who received any of these AED models since October 19, 2009 can visit http://www.cardiacscience.com/AED1952 to determine if they have an

affected AED. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.

Go to   http://www.fda.gov/Safety/Recalls/UCM200123  for more information.

 

Philips Defibrillators Recalled Due to Faulty Chip

Philips Electronics has announced a recall of 5,400 of its HeartStart FR2+ automated external defibrillators. The recall was announced after the company learned that there may be a problem in one of the memory chips that could prevent the defibrillator from working properly. The recalled products were sold worldwide, although it is expected that customers in the US will be mainly affected by the recall.

The affected defibrillators were manufactured in 2007 and early 2008. Models M3860A and M3861A, distributed by Philips, and M3840A and M3841A, distributed by Laerdal Medical have been recalled.

OCT-01-09: Faulty chip causes defibrillator recall [TG Daily: Philips Defibrillator Recall]

 

 

Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillator (AED) Recall

Only the Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers
37026963, 37026983, 37026984, 37026997, 37027002
37027008, 37027039, 37027040, 37027049, 37027053
37027063, 37027065, 37027066, 37027070, 37027071
37027073, 37027075, 37027090, 37027099, 37027105
37027122, 37027197, 37027529, 37027569, 37031393
37037850, 37037893, 37037986, 37038002, 37038211
37038365, 37135986, 37154526, 37154638
The serial number is located on the underside of the device.

The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008.

This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

Reason for Recall: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Public Contact:   Physio-Control Customer Care

                             1-800-442-1142, 6 AM through 4 PM Pacific Time

FDA Comments:  Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

 

 

ZOLL Medical Corporation, ZOLL AED Plus Defibrillator Class 1 Recall

Date Recall Initiated:  February 12, 2009


Product:   ZOLL AED Plus Defibrillator  This product was manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009.

Recalling Firm:      ZOLL Medical Corporation

                                269 Mill Road

                                Chelmsford, Massachusetts 01824



Reason for Recall:  The AED failed to deliver the defibrillation energy.

Public Contact:  The company may be contacted at 1-978-421-9655.

FDA District:  New England

FDA Comments:   The company sent their distributors and customers an initial recall letter on February 12, 2009 by certified mail. This letter instructed customers to replace their batteries every three  years. The company then sent their distributors and customers a follow-up recall letter on March 31, 2009 by certified mail. This letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels.

ZOLL will send an email notice to all customers who included their email address as part of their contact information. ZOLL will also publish information about the recall in industry magazines.

For more information about this recall, please see the company’s website at: http://www.ZOLLAEDPlusbatteryhelp.com

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

 

 
 
 
 
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LTS reporting forms:

Practical Skill Assessment Form  (Service Documentation for Initial & Annual Review)


AED Medical Director's Review Form  (To submit to your EMS Agency Medical Director  with the Code Summary each time the AED is used)


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 *LINKS:
 
*The LTS EMS Council, and Lycoming County Government are not responsible for the content or accuracy of information provided on the website links on this site.
 
 
OF INTEREST. . .
 
Pennsylvania becoming model for highway heart safety

February 2,  2004

 Automated external defibrillators (AEDs) have been placed at five rest stops on Interstate 80 in Pennsylvania near Harrisburg. The lifesaving devices were donated by the Pennsylvania Chapter of the American College of Cardiology. AEDs were installed last February along the Pennsylvania Turnpike.

“PennDOT views the safety of all motorists as a primary objective,” said Robert Peda, director of PennDOT's Bureau of Maintenance and Operations. “We’re proud that Pennsylvania is leading the way with defibrillator installations on I-80.”

 

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For more information contact:
 
Name:  Wendy S. Hastings
Title:  Director
Office:  LTS EMS Council
Email:  whastings@lyco.org
Voice:  PHONE: 570-433-4461
Fax:  FAX: 570-433-4435
 

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Last Updated: 2/9/2018 3:00 PM
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