Events

Recall of Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor(when used with ECG or EEG monitoring)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific Pty 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-01327-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01327-1
  • 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
    Radiometer has recently received reports of occurrences of the tcm5 causing interferences on ecg and eeg monitors. there is a possibility that tcm5 flex / basic can cause interferences to ecg or eeg measurements, however, only when applied on the same patient.For this reason the instructions for use include the following warning:warning – risk of interferenceother instruments sensitive to electromagnetic interference may be affected by the tc measurement. if this is the case, contact authorised service personnel.The described effect may potentially lead to incorrect measurement results by 3rd party devices, such as an ecg monitor due to interference by the tcm5 flex / basic monitor. these incorrect measurement results may potentially lead to incorrect treatment or management of the patient.
  • Action
    Radiometer is advising users who perform ECG measurements in combination with the TCM5 FLEX/ BASIC on a patient to implement one of the counter measures below to reduce/prevent the interference. 1. Disconnect the TCM5 FLEX/BASIC from the mains supply and run it on battery only. This will prevent the interference from occurring on an ECG or EEG monitor. 2. Do not use both the TCM5 FLEX/BASIC and an ECG or EEG monitor simultaneously on the same patient. Radiometer is revising the Instructions for Use and will provide these to customers when available. Radiometer will contact affected customers when a solution becomes available.

Device

Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor(when used with ECG or EEG monitoring)
  • Model / Serial
    Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor(when used with ECG or EEG monitoring)All Serial NumbersARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd