NOTE: Please do not contact OFPC regarding this Manufacture's Urgent Notification. Please contact
the Manufacturer or your distributor if you have any questions or concerns. Contact information is
provided below. Cardiac Life Products, Inc. has requested the assistance of the Office of Fire Prevention & Control
to communicate an urgent notice related to a medical device correction for certain Cardiac Science
Powerheart automated external defibrillators (AEDs). Please see the Notice below. The intent of this bulletin is to quickly share this information to as many owners of the Cardiac Science
AEDs, including those who have received a donated unit. The upgraded software will make the AED
unit more sensitive to identifying any resistor issues which may occur over the lifetime of the Cardiac
Science Powerheart AEDs' use. Below are listed details to help the AED owner better understand what is to be expected. The link
should not take more than 15 minutes on a high speed connection. At this site,
www.cardiacscience.com/aed175, the user will find the following information. o Serial number look up AED IFUs
o Software Update Instructions
o Customer FAQs
o Form to order software update kit
It is important to send the update response back to Cardiac Science that the AED has been updated. This is carefully explained in the instructions. The AED owner will need the following requirements in order to update:
• A serial cable to connect the Powerheart AED to the PC. If the customer does not have
the cable, they can call Cardiac Life Products, Inc. , offices at 585-267-7895 or 866-710-1970 to order a
cable free of charge. Important Points to know:
If the Cardiac Science AED device currently operates according to the AHA/ERC 2000 Guidelines,
it will change. AEDs built prior to the new Guidelines which had not been previously updated will
update automatically. If the unit currently operates according to the AHA/ERC 2005 Guidelines, it will not change.
Should I keep my devices in service until the update is available for all other units? Until the update is available, Cardiac Life Products, Inc. , recommends you keep your device in service and perform the tests indicated for Daily and Monthly Scheduled Maintenance as outlined in your Operator and Service manual. A copy of these procedures is available at www.cardiacscience.com/aed175. At this site, you may confirm if your AED is affected and register for automatic e-mail reminders to conduct scheduled maintenance. What if I notice that the device's Rescue Ready indicator is red?
If your device Rescue Ready indicator is red, you should contact technical support at 800.426.0337 (choose option 1) in the United States. Outside the US, contact Cardiac Science at +44.161.926.0011 or contact your local Cardiac Science representative, Cardiac Life Products at 866-710-1970. If the chance of this error occurring is rare, why is Cardiac Science choosing to perform this update?
Cardiac Science is committed to providing the highest quality products and services to our customers. Despite the fact that the chance of this issue occurring is rare, Cardiac Science will perform this update to further reduce the risk associated with this issue and help ensure that every device functions as intended every time.
How many models are affected?
Certain automated external defibrillators (AEDs) manufactured between August 2003 and August 2009 are affected by this action. The affected models include: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and CardioVive 92531, 92532, and 92533. Mary Wynne President WBE/SB NYS Contract # PC64094, PC63996 http://www.nysaed.com/ PO Box 25755 Rochester, New York 14625 Phone: 866-710-1970 Fax: 585-267-5218 Cell: 585-738-1928