Events

Rappel de BiPAP A 40 Ventilatory Support System; Detachable Battery Module, USA/INTL

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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-2017-RN-01438-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-11-27
  • 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-01438-1
  • 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
    Philips respironics has identified an issue where a non-conforming part (side panel) was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module (part number 109677). the issue results in the inability to connect the bipap a40 device to the detachable battery module during setup before putting the ventilator into operation on a user; therefore, there is no safety risk to the patient. the impacted bipap a40 units continue to work properly in configurations without the detachable battery module. a non-conforming part was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module.
  • Action
    1. Complete the inspection of the devices for the potentially faulty side panel per the inspection instructions provided with the letter. 2. Complete and return Business Reply Form (BRF) and list the total quantity inspected, the quantity of correct devices, and the quantity of incorrect devices. 3. Contact your local Customer Service who will provide direction on how to return your device(s) for any confirmed faulty side panel replacement.

Device

BiPAP A 40 Ventilatory Support System; Detachable Battery Module, USA/INTL
  • Modèle / numéro de série
    BiPAP A 40 Ventilatory Support SystemProduct code: 1111171Detachable Battery Module, USA/INTLProduct code: 1096770ARTG number: 200289
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA