NOTE: THIS DOCUMENT HAS BEEN UPDATED - PLEASE SEE Defective Cardiac Science Corporation Powerheart, CardioVive, Nihon Kohden, and GE Responder External Defibrillators: Updated July 19, 2010
The purpose of this updated communication is to provide users of certain Cardiac Science Corporation external defibrillators with additional information about the expanded scope of the recall of these devices and update FDA’s recommendations since we issued an initial communication on this issue on November 19, 2009.
Audience: Users of certain Cardiac Science external defibrillators
Medical Specialty: Cardiology
Device: Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder External Defibrillatorsmanufactured between August 2003 and August 2009. These devices are used for emergency treatment of victims with symptoms of sudden cardiac arrest who are unresponsive and not breathing.
Expanded Scope of Recall
Cardiac Science Corporation issued a press release (11/13/09) alerting users of its Powerheart, and CardioVive external defibrillators of defective components and reported failures. This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. Approximately 280,000 Cardiac Science external defibrillators worldwide are potentially affected by this problem.
The updated list of affected models includes:
- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, and 9390E
- CardioVive 92531, 92532 , and 92533
- Nihon Kohden 9200G, and 9231
- GE Responder 2019198, and 2023440
In addition to failure to deliver needed shocks, other problems with these devices may include:
- Interruption of electrocardiography (ECG) analysis that prevents shock delivery,
- Failure to recognize pad (electrode) placement during use, or
- Interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if an ECG analysis is successfully conducted.
Improper functioning of the device during a rescue attempt may prevent resuscitation of patients and lead to serious adverse health events or death. The Daily/Weekly/Monthly self-tests performed by the affected devices’ software to ensure proper functioning may not detect defects in certain electronic components that can lead to device failure. Cardiac Science issued a software upgrade for the devices’ self tests on 2/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects. Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order.
FDA recommends that all users of Cardiac Science external defibrillators affected by this recall take the following precautions:
- High Risk and/or Frequent Use Facilities should obtain an alternate external defibrillator or immediately arrange for repairs or replacement of the Cardiac Science external defibrillator. Examples of such facilities include hospitals, ambulances, clinical settings, high-risk patient population facilities, facilities with only one external defibrillator, and emergency transport settings.
- All other users, including Home Users and Public Access Defibrillation Programs, should take the following steps while arranging for repair or replacement of the Cardiac Science external defibrillator.
- If an alternate external defibrillator is available, use it until the Cardiac Science Corporation external defibrillators have been repaired or replaced, or consider obtaining another external defibrillator.
- If an alternate external defibrillator is not available, Cardiac Science external defibrillators may be used if needed, as the units may still be able to deliver the necessary therapy. The consequences of not attempting to defibrillate a patient outweigh the risk that these devices may fail.
To contact Cardiac Science in the U.S. call 425-402-2000 (press option 1). Outside the U.S. call +44-161-926-0011; or email AED175@cardiacscience.com).
On March 8, 2010, FDA classified the firm’s field correction as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. An FDA recall notice was posted on the CDRH Website.
If FDA receives any additional information that might affect the use of these external defibrillators, we will make that information available.
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect any electronic or mechanical problem(s) with an external defibrillator, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
To help us learn as much as possible about the adverse events or inability of an external defibrillator to deliver defibrillator therapy, please include the following information in your reports, if available:
- Make, Model, and Serial number of the device
- The initial and final conditions of patient
- Description of the device problem and sequence of events that occurred
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@cdrh.fda.gov or 800-638-2041.