Events

Rappel de Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00081-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00081-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Radiometer TCM5 FLEX / BASIC Transcutaneous MonitorAll Serial NumbersARTG Number: 140333
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd