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Archive - Nov 24, 2009

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Cardiac Science Clarifies Voluntary Medical Device Correction

BOTHELL, WA–Cardiac Science announced
earlier last week a voluntary field
corrective action due to a very rare occurrence found pertaining to a device
resistor in one of its AED models.

The probability that this would occur in a Cardiac Science AED
is less than 0.0013%. With approximately 300,000 Cardiac Science AEDs in use,
this issue contributed to a device’s inability to deliver therapy in two reported occurrences over a period spanning more than six years. This issue is predicted to occur in approximately one in 75,000 devices
produced before August, 2009.