Wednesday, April 28, 2010

Defective Cardiac Science Corporation Powerheart, CardioVive, Nihon Kohden, and GE Responder External Defibrillators: Updated April 27, 2010

From the FDA site:

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 release2 (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.

Updated Recommendations

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.

More here.

Reblog this post [with Zemanta]