Device Recall Philips 의 리콜

Recall

72477

Class 2

Z-0273-2016

2014-11-19

2015-11-13

Terminated

United States

2017-09-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141182

When a philips monitor/defibrillator is receiving an ecg signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (efts) while connected to ac power: on the heartstart mrx and heartstart xl, eft noise can be misinterpreted as an r-wave. on the heartstart xl+, eft noise can disable ecg monitoring, and potentially interrupt demand mode pacing.

Philips sent an Urgent - Field Safety Notice dated November, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips plans to take to remedy the issue. A replacement cable will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. 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: Prior to receiving a replacement sync cable, you can continue to use affected sync cables, provided that they are only used to connect the ECG Out jack on the monitor/defibrillator to the ECG (input) port on a bedside monitor. The issues described in this letter do not impact this application of the sync cable. Affected sync cables should not be used to connect the ECG Out jack of a bedside monitor to the ECG (input) port on the monitor/defibrillator. For further questions please call (800) 722-9377.