Events

Rappel de Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz Controllers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hill-Rom 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-2017-RN-01388-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-06
  • 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-01388-1
  • 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
    Hill-rom has become aware of a potential issue with some international (220 - 240 v, 50 hz) compella air surfaces. within the low air loss mattress, a hose in the foot section is prone to kinking and occluding air flow. this can result in heat rising and failure of the air compressor inside the compella controller. if the compressor fails, the controller can no longer function correctly to maintain air flow to the compella mattress, in which case the controller will alarm. to date, there have been no reported patient safety related complaints associated with this issue.
  • Action
    Hill-Rom is advising users that the affected systems will be corrected as a permanent fix. The systems can continue to be used until the correction has been completed.

Device

Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220...
  • Modèle / numéro de série
    Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz ControllersSerial Numbers: CR600003 to CR604302 and CU200002 to CU200072Manufacturing date range is from March 2015 – March 2017 ARTG Numbers: 239273 and 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd