Posted on 11/19/2009

The FDA has issued a preliminary analysis of the Cardiac Science Powerheart and CardioVive
Automated External Defibrillator(AED) G3 Series manufactured between
August 2003 and August 2009. Affected models include the following:

  • Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
  • CardioVive 92531, 92532 , and 92533

Problem and Recommendations

Because the AED display screen and/or audible indicators may not
accurately indicate whether the device is functioning properly or will
function properly at time of use, FDA encourages users of the affected
Cardiac Science Powerheart and CardioVive AEDs to follow these
precautions:

  • If alternate AEDs are available, then use those AEDs until the Cardiac Science Corporation AEDs have been repaired or replaced, or consider obtaining another AED.
  • Contact the company immediately to arrange for
    repairs or replacements (in the U.S. at 425-402-2000 (press option 1)
    or outside of the U.S. at +44-161-926-0011; or email AED175@cardiacscience.com).
  •  For Home Use and Public Access Defibrillation Programs:
    If an alternate AED is not available, FDA recommends using the
    Powerheart and CardioVive AEDs 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.
  • For Hospitals, Ambulances, Clinical Settings and Emergency Transport Settings:
    If an alternate AED is not available, then FDA recommends that trained
    responders ( i.e., personnel certified in Advanced Cardiac Life
    Support), use manual defibrillators if they are available, or use the
    Powerheart and CardioVive AEDs if manual defibrillators are
    unavailable. The Powerheart and CardioVive units may still be able to
    deliver the necessary therapy.

Background

Cardiac Science Corporation has received multiple complaints related
to defective components in these AEDs that indicate the affected
devices may not deliver electric shocks and that the devices’ self-test
may not detect the defect in advance of their use. The specific
problems 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.

The specific problem with these AEDs is that defects in certain
electronic components may not be detected by the device’s
Daily/Weekly/Monthly self-tests. These defects can cause improper
functioning of the device during a rescue attempt, which may prevent
resuscitation of patients and lead to serious adverse health events or
death. Normally, users should always check the status indicator on the
front of the AED to see whether the device is rescue-ready (green light
is displayed). However, visual inspection of a green light may not reveal defective or non-working components inside the AED.

In some complaints, the device’s self-test detected certain
component failures prior to use. In other complaints, the failures were
only detected during patient use when the device did not perform
properly. The firm is planning on releasing a software update in May
2010 that they claim will detect all failures. FDA is conducting an
evaluation of the firm’s actions to verify that the defects are
permanently corrected.

FDA Activities

FDA is gathering more data about this situation to better understand
its potential public health impact. As FDA learns more, we will make
available any new information that might affect the use of these AED
devices. This document reflects FDA’s current analysis of available
information, in keeping with our commitment to inform the public about
its ongoing safety reviews of medical devices. The nature, magnitude
and possible public health impact of this situation are not yet clear.

SOURCE: FDA

         

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