Events

Recall of Philips Sync Cables and Philips ECG Out Cables

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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
    RC-2017-RN-00900-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00900-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Philips Sync Cables and Philips ECG Out Cables
  • Model / Serial
    Philips Sync Cables and Philips ECG Out CablesPhilips Sync CablesModel Numbers: M1783A and M5526AECG Out CablesModel Number: 989803195641ARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA