Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor 의 리콜

Recall

RC-2018-RN-00081-1

Class I

2018-02-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00081-1

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.

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.