Events

Rappel de Hamilton Medical MR1 Ventilator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

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-2016-RN-01133-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • 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-2016-RN-01133-1
  • 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
    An issue has been identified where the oxygen tubing and the oxygen connector of the hamilton-mr1 became loose during the preparation for ventilation. in the case of loose oxygen tubing during operation, the ventilation is continued and the “oxygen supply failed” alarm is triggered if the oxygen setting is above 21%. the oxygen connector may hurt the patient and the operator due to the high pressure of the oxygen and uncontrolled movement of the tubing. there have been no injuries as a result of this issue.
  • Action
    Taleb Medical is advising users to check the oxygen connector screws for tightness as an immediate measure. Tighten with a screwdriver if necessary. Do not over tighten the screws as this can damage the thread. If the oxygen connector cannot be tightened or if the screw-hole threads are damaged, do not use the ventilator. A new O2 mixer mounting plate will be installed as a permanent correction.

Device

Hamilton Medical MR1 Ventilator

Manufacturer

The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia