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

Recall

RC-2017-RN-01327-1

Class I

2017-10-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01327-1

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.

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.