The purpose of this update is to provide users of certain Cardiac Science Corporation external defibrillators with updated information about the ongoing recall of the devices identified in this notice. FDA issued an initial communication on this issue on November 19, 2009, and an updated communication on April 27, 2010 that contained information about the expanded scope of the company’s recall and additional recommendations.
Audience: Users of certain Cardiac Science external defibrillators
Medical Specialty: Cardiology
Device: Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder External Defibrillators manufactured 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.
The affected models include:
- 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
Problems with these devices may include:
- Failure to deliver shocks,
- 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 on 6/29/10 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.
Since FDA issued its last communication on this recall on April 27, 2010, Cardiac Science Corporation has developed a replacement plan for high risk and/or frequent use facilities. The company has prioritized the replacement of the devices into two groups:
- First Tier: Police, Fire and Ambulance
- Second Tier: Hospitals Medical Clinics, Assisted Living Facilities, and Dialysis Centers
Cardiac Science will contact all users to determine the specific replacement schedule for each user. Follow the company’s instructions for replacement.
FDA recommends that all other users, including Home Users and Public Access Defibrillation Programs, and facilities with only one external defibrillator not belonging to one of the First or Second Tier replacement groups, take the following steps:
- Obtain the software upgrade from the Cardiac Science website that corresponds with your external defibrillator.
- While these software upgrades detect some failures but not others, Cardiac Science external defibrillators may be used if needed, as the units are likely to still be able to deliver the necessary therapy. The consequences of not attempting to defibrillate a patient outweigh the remote possibility that some of these devices may fail.
- If the device indicates that service is needed, please contact Cardiac Science for repair or replacement of the device.
- Use an alternate external defibrillator if available, until the Cardiac Science Corporation external defibrillators have been repaired or replaced.
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 Industry and Consumer Education (DICE) at DICE@cdrh.fda.gov or 800-638-2041.