Philips Sync Cables and Philips ECG Out Cables 의 리콜

Recall

RC-2017-RN-00900-1

Class II

2017-07-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00900-1

Philips originally advised of electrical interference via sync cables (tga ref: rc-2014-rn-01291-1), where affected cables were replaced. philips is now advising users to cease using and dispose of sync cables and ecg out cables, as when using a sync cable or ecg out cable with the heartstart mrx or heartstart xl, eft noise may be mistaken as an r-wave. if this occurs when performing synchronised cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronised to eft noise instead of the r-wave of the patient’s actual ecg.

Philips is requesting users read the supplied notice and then: 1. Remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the acknowledgement form, which should be returned to Philips; 2. There are 3 options for the user to synchronise the MRx or XL+ monitor/defibrillators, so the synchronisation function is not lost. In summary, these methods are: -The shock pads ECG can be used for synchronisation. -If the user places or replaced 3 leads ECG pads, the resulting ECG can be used for synchronisation. -The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy. For further information, the customer should refer to the Instructions for Use that describe the recommended approach for performing cardioversion.