Powerheart G5s & G5A Automatic External Defibrillators (AEDs) 의 리콜

Recall

RC-2014-RN-00109-1

Class I

2014-02-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00109-1

Cardiac science has determined that certain powerheart g5 automatic external defibrillators (aeds) shipped between june 21, 2012, and march 1, 2013, may have been manufactured with a defective electrode connector. some of these g5 aeds have been found with missing spring contacts in the electrode connector assembly. when the spring is missing, the aed may not recognise that the pads have been placed on the patient during a rescue attempt. the aed voice prompts will progress until they reach the pads placement (peeled) step. at that point the aed will, regardless of whether the pads are placed onto the patient's chest or not, continuously repeat "place pads firmly onto patient's chest..." after 2 minutes, the pad placement prompting will time out and the aed will begin cpr mode. if the issue occurs, 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.

Cardiac Science is advising users that affected units will be required to be sent to Cardiac Science's head office for repair. Units will be returned to users the same day they are received by Cardiac Science. This action has been closed-out on 11/04/2016.