Philips HeartStart MRx Monitor/Defibrillator 의 리콜

Recall

RC-2014-RN-00188-1

Class I

2014-02-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00188-1

When used in hospital transport and pre-hospital (ems) environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear also could cause the mrx to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.

Philips will be inspecting affected units and implementing hardware corrections if required. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. However, customers are advised to ensure that ongoing therapy connection inspections are undertaken on MRx devices to detect wear. Customers are advised to remove affected devices immediately from use and contact Philips to arrange service.