Service Announcements & Upgrades
Phone US: 425.402.2000
or: 800.426.0337
Fax: 425.402.2022
or: 800.426.0337
Fax: 425.402.2022
Email U.S.: techsupport@cardiacscience.com Technical Support Hours:
5 a.m. to 4:30 p.m. Pacific Time, M-F
or Outside the U.S.: internationalservice@cardiacscience.com
Date: 11/13/2009
Title: Voluntary Medical Device Correction: AED resistor and AED relay
Full Description:
Cardiac Science has determined certain automated external defibrillators (AEDs) manufactured between August 2003 and August 2009 may experience a rare product issue. These AEDs have resistors which may fail and the failure will not be detected by the AEDs’ periodic self-tests. If the issue were to occur, the AED may not be able to deliver therapy during a rescue attempt and may affect resuscitation of the patient. This could lead to serious adverse health events or death. The affected models include Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and CardioVive 92531, 92532, and 92533, manufactured between August 2003 and August 2009.With approximately 300,000 Cardiac Science AEDs in use, this issue contributed to an AED’s inability to deliver therapy in two reported occurrences over a period spanning more than six years. The probability that this would occur in your AED is remote. This issue is predicted to occur in approximately one in 75,000 AEDs produced before August, 2009.
The mandatory software update is now available for all affected models. This update enhances the AED’s capability to detect the resistor issue during normal self-test procedures. Please download and install this update immediately.
Recommended AED Maintenance Procedure1
Perform the following tests per the schedule indicated:
Daily Maintenance
Check the Status Indicator to ensure that it is GREEN. When the indicator is GREEN, the AED is ready for a rescue. If the status indicator is RED:
- In the US, call Tech Support at +1.800.426.0337, option 1.
- Outside the US, call +44.161.926.0011 or your local Cardiac Science representative.
Monthly Maintenance
Perform the following procedure each month (28 days):
1. Open the AED lid.
2. Wait for the AED to indicate status: Observe the change of the STATUS INDICATOR to RED. After approximately five seconds, verify that the STATUS INDICATOR returns to GREEN.
3. Check the expiration date on the electrodes.
4. Listen for the voice prompts.
5. Close the lid and observe the change of the STATUS INDICATOR to RED. After approximately five seconds, verify that the STATUS INDICATOR returns to GREEN. If the STATUS INDICATOR does not return to GREEN:
- In the US, call Tech Support at +1.800.426.0337, option 1.
- Outside the US, call +44.161.926.0011 or your local Cardiac Science representative.
1 Excerpted from Powerheart AED G3 model Operator and Service Manual.
Reminder Registration
If you would like a weekly emailed maintenance reminder, please share your email address in the box below.Serial Number Search
To determine if a device is affected by this voluntary medical device correction, please enter one or more serial numbers in the box below. Locate the serial number on the back of your device. Serial numbers are marked SN and contain no letters.Unsubscribe
Enter your email below to unsubscribe from the weekly reminder emails.If at any time you determine that your AED is not rescue ready (the status indicator is red),
• In the US, please contact our Technical Support team at 800.426.0337 (select option 1).
• Outside the US, please contact your local Cardiac Science representative or Cardiac Science at +44.0161.926.0011.
We apologize for any inconvenience this issue may create. If you have questions regarding this alert, contact us at 877.901.1788 or aed175@cardiacscience.com