Events

Rappel de BVM (Bag-Valve-Mask) Manual Resuscitation Systems

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Intersurgical Australia 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-00058-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-01-16
  • 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-00058-1
  • 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
    A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the back plate of the self inflating bag being orientated incorrectly. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma.
  • Action
    Intersurgical is advising users to inspect stock and quarantine affected units for return. In instances where an alternative product is not available, Intersurgical is advising users to inspect each device before use to determine if it is affected by the issue. If the device is not affected, it can be safely used.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modèle / numéro de série
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsReference Number: 7150000, 7151000, 7152000, 7153000, 715400Lot Numbers: 7150000 – 372894, 7151000 – 372886, 7152000 – 372893, 7153000 – 372892, 7154000 – 370753 ARTG Number: 225855 (Intersurgical Australia Pty Ltd - Resuscitator, pulmonary, manual, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd