BOTHELL, WA– Cardiac Science is initiating a voluntary field correction after it was
determined certain automated external defibrillators (AEDs) may experience a
rare product issue in which the AED may not be able to deliver therapy during a
resuscitation attempt. Device failure may affect resuscitation of the patient,
which could lead to serious adverse events or death. These AEDs have electronic
components which may fail and the failure may not be detected by the device's
periodic self-tests. The affected models include the Powerheart 9300A, 9300C,
9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533
devices.
Cardiac Science has
received a total of 64 complaints concerning four resistors within certain
AEDs. Two of these complaints were associated with a failure to deliver
therapy. This issue is predicted to occur in approximately one in 75,000 AEDs
manufactured between August 2003 and August 2009. The company has also received
114 complaints regarding "Service Required" messages resulting from a
specific relay switch failure. There have been no reported instances where this
issue has resulted in an inability to deliver therapy.
Until a correction
is available in May, 2010, the company strongly advises customers to check the
status indicator on the front of the AED and follow the procedures documented
in the materials accompanying the AED. The company advises that customers leave
their AEDs in service.
"When customers
choose a product from Cardiac Science, they expect outstanding
reliability," said Dave Marver, president and chief executive officer.
"We understand the role our products play in public health and are taking
appropriate measures to further improve the performance of our products."
The company has
implemented more stringent testing of the components and all AEDs produced
since August, 2009 are unaffected. Customers in possession of an AED that may
exhibit either of these issues will be notified immediately. A software update
to address the resistor issue will be available by May, 2010. This software
update will enhance the AED's self-test capabilities and improve detection of
the issue. In the interim, the company advises customers to keep their AEDs in
service and follow the normal testing and maintenance procedures found in the
Operator and Service Manual. A copy of these procedures is available at www.cardiacscience.com/AED175.
At this site, customers may confirm if their AED is affected and register for
automatic e-mail reminders to conduct scheduled maintenance.
If the AED is not rescue
ready (the indicator is red) customers should contact the company immediately
at 425.402.2000 (option 1) within the United States. Outside the US contact
+44.161.926.0011 or the local Cardiac Science representative. Customers can
also email the company at AED175@cardiacscience.com.