Events

Rappel de Hamilton Medical C3 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-2017-RN-01174-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-28
  • 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-2017-RN-01174-1
  • 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
    Taleb medical has received a customer complaint relating an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. an analysis has identified that after two and a half years, the battery fuel gauge may indicate a higher battery charge as to what is actually available. the technical failure 444001 ”low battery” high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode.When batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode.
  • Action
    1. The operator or service personnel should make themselves familiar with the batteries’ date of installation and manufacturing date and react in time if the battery is more than two years in operation or maximum three years from the manufacturing date. 2. The battery’s manufacture date is engraved on the top of the battery connector (see supplied letter for details). a. Any battery in operation for more than two years prior to the actual date should be replaced. b. If the battery is less than two years old attach a label stating the manufacturing date or the commissioning date of the battery (if known) manually on the battery or the ventilator which contains this battery and check it periodically against the current date. c. Slide the battery back into slot until it clicks and close the battery door. 3. Complete and the supplied customer acknowledgement form and return to Taleb, 4. Taleb will arrange for the replacement of affected batteries.

Device

Hamilton Medical C3 Ventilator

Manufacturer

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