Device Recall ECG Out Cable 의 리콜

Recall

78702

Class 2

Z-0348-2018

2017-07-17

Terminated

United States

2018-07-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160148

Issue with ecg out cables. when a philips monitor/defibrillator is receiving an ecg signal from an auxiliary bedside monitor via a sync cable or ecg out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (efts): " on the heartstart mrx and heartstart xl, eft noise may be misinterpreted as an r-wave. " on the heartstart xl+, eft noise can disable ecg monitoring and potentially interrupt demand mode pacing*. *note: it is contrary to the xl+ instructions for use to perform demand mode pacing while using the ecg out cable or obtaining the ecg signal from a bedside monitor. the xl+ instructions for use includes the following warning: when pacing in demand mode, the ecg cable from the patient must be directly connected to the heartstart xl+. if the user follows this warning, this problem cannot occur on the xl+.

Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Customers should remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the attached reply form, which should be returned to Philips. Customers should retain a copy of the reply form. The customer should follow the Instructions for Use that describe the recommended approach for performing cardioversion with the XL+ and MRx monitor/defibrillators. The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy; this is the preferred source of an ECG waveform for synchronization.