Service Announcements & Upgrades
Date: August 2011
Title: Attention Powerheart® AED G3 Owners
Full Description:Cardiac Science is sending notification letters to our US customers beginning in August 2011.
This letter advises customers about the Rescue Ready® self-testing features in our Powerheart AEDs. Cardiac Science has designed extensive self-testing to ensure each Powerheart AED is Rescue Ready when needed. These self-tests include verifying the battery has an adequate charge, internal circuitry is functioning as expected, and pads are connected properly.
As indicated in the “Instructions for Use” (provided with every AED), the STATUS INDICATOR on the AED will be RED when the daily, weekly, or monthly self-test determines maintenance is required. An audible beep will also sound every 30 seconds until the lid is opened, or the battery power is depleted.
Cardiac Science continually evaluates product performance data. We have determined that two particular self-test errors have been a source of a small number of continued “Service Required” status messages. In the past 6 years these two errors have been reported only 334 times in the approximately 380,000 Powerheart AED G3 devices in use worldwide. In the rare instance that these errors occur, the device will indicate that it is not Rescue Ready and the screen display will indicate “Service Required.” We have no reports of these errors occurring during a rescue attempt.
We advise that customers:
- Check the status of the AED every day to ensure it is Rescue Ready.
- Perform the regularly scheduled maintenance as outlined in the Powerheart AED “Operator and Service Manual” provided with each AED. (This document can be downloaded from this web page.)
Cardiac Science believes there are no additional actions that could be taken to reduce the risk of an AED failing to perform during a rescue attempt. We are committed to product improvement and will continue to monitor our product performance data. We will provide you with an update if our recommendations change. The U.S. Food and Drug Administration (FDA) is aware of this situation. If you have questions about this communication, call our Technical Support team at +1.800.426.0337 (option 1) or email us at firstname.lastname@example.org.
On this web page, you will find PDFs of:
- The customer letter
- Frequently Asked Questions
- Instructions for Use for Cardiac Science G3 AEDs
- Operator and Service Manuals for Cardiac Science G3 AEDs