Events

Recall of ECG OUT SYNC CABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    142706
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware that 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*. 1. *note: it is contrary to the instructions in the xl+ instructions for use (ifu) to perform demand mode pacing while using the sync cable to provide the ecg signal from a beside monitor. the xl+ ifu 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+.

Device

ECG OUT SYNC CABLE
  • Model / Serial
    Model Catalog: M1783A (Lot serial: ALL); Model Catalog: M5526A (Lot serial: ALL); Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL); Model Catalog: M4735A (Lot serial: ALL); Model Catalog: 861290 (Lot serial: ALL)
  • Product Description
    ECG OUT SYNC CABLE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC