HeartStart FRx, HeartStart Home, and Heartstart OnSite 의 리콜

Recall

RC-2018-RN-00229-1

Class I

2018-05-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00229-1

Philips has become aware of a specific electronic failure with one of the resistors. virtually all of these resistor-related failures were detected through the devices’ automatic self-testing, alerting the user by issuing audible chirps. however, in rare instances, self-tests might not identify a problem and the device might not deliver a shock when needed. to date, philips is aware of 13 instances in which this component failed during treatment, out of more than 45,000 uses in which shock therapy was delivered. in all these instances, the device delivered at least one shock before failure. among the cases for which the patient outcome is known, in overseas jurisdictions, 5 patients died and 2 patients were successfully resuscitated and survived.The in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest patient is in need of shock therapy.

Upon receipt of the Customer Letter, users are asked to conduct a self-test on their device as per the instructions outlined in the current IFU using the details given below: • Check the pads label for the expiry date, replace if expired • Check the battery label for the expiry date, replace if expired • Depress the blue “i”, listen for the voice prompt to provide device status • Remove and reinsert the battery, allow the self-test to complete. Users are also requested to refresh their understanding of the Audible Chirps from the AED as detailed in the Customer Letter.