Events

Recall of Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor

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-2018-RN-00081-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00081-1
  • 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 previously informed users that they had received reports of occurrences of the tcm5 causing interferences on ecg and eeg monitors (tga ref: rc-2017-rn-01327-1).There is a possibility that tcm5 flex/basic can cause interferences to ecg or eeg measurements, however, only when applied on the same patient.The problem may also concern other highly sensitive devices including: ecg, eeg, emg, mmg, eog, gsr, meg, icg. 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 to choose one of the options below in order to avoid the issue from occurring. Option 1: Connect the TCM5 monitoring system to a grounded Ethernet network using a shielded Ethernet cable. Please contact Radiometer if this option is selected. Radiometer will assist in verifying that the Ethernet network is indeed grounded and in selecting types of Ethernet cables verified by Radiometer. Option 2: Disconnect the TCM5 monitoring from the mains supply and run it on battery only. Users can use the monitor for up to 4 hours with a fully charged battery. Option 3: If alternative monitoring system is available consider to use that while waiting for the final solution from Radiometer. In case none of the above options are feasible Radiometer requests users to refrain from combining the TCM5 FLEX/BASIC measurement with an EEG or ECG measurement.

Device

Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor
  • Model / Serial
    Radiometer TCM5 FLEX / BASIC Transcutaneous MonitorAll Serial NumbersARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd