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.
Cardiac Science is creating a Software Update for the impacted
population to continue its commitment to as close to 100% performance
as possible.
The corrective action does not impact units being produced.
For more information, see attachments.
SOURCE: Cardiac Science
| Documents | Size |
|---|---|
| Cardiac_Science_-_Customer_-_Partner_FAQ_-_FCA_-_Nov_2009.pdf | 32.63 KB |
| Cardiac_Science_-_Supplementary_Update_FAQ_-_112409.pdf | 59.79 KB |