Philips M1783A and M5526A 12 Pin Sync Cables 의 리콜

Recall

RC-2014-RN-01291-1

Class I

2014-12-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01291-1

The following problems were found during internal testing:if electrical fast transits (eft) noise is injected into the monitor/defibrillator via ac mains power, and the monitor/defibrillator is connected to and receiving ecg signals from an auxiliary bedside monitor with an m1783a/m5526a 12 pin sync cable (8/24 feet) via the monitor’s ecg out port, then:1. when using a sync cable with the heartstart mrx or heartstart xl, eft noise can be mistaken as an r-wave. if this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to eft noise instead of the patient’s actual r-wave. 2. when using a sync cable with the heartstart xl+, eft noise can disable ecg monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. a power cycle is required to resume ecg monitoring, however, fixed mode pacing is not impacted by this issue.

Philips will replace all affected sync cables with a new sync cable free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for a replacement. This action has been closed-out on 05/12/2016.