Events

Recall of Device Recall ECG Out Cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    78702
  • Event Risk Class
    Class 2
  • Event Number
    Z-0348-2018
  • Event Initiated Date
    2017-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160148
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    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+.
  • Action
    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.

Device

Device Recall ECG Out Cable
  • Model / Serial
    M1783A/M5526A 12-pin Sync cables  All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    1067 US customers 163 Canada, 917 International
  • Product Description
    ECG Out Cable - Heartstart MRx || M1783A/M5526A 12-pin Sync cables || All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. || Manufactured - September 4, 2002 October 8, 2014
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA