Events

Rappel de SLE 5000 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 AHC Solutions 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-2013-RN-00855-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-23
  • 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-2013-RN-00855-1
  • 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
    The manufacturer has identified a potential risk associated with the fp110-410 psu (power supply unit). their internal monitoring and investigations have identified a suspect batch of electrolytic capacitors used on the main pcb (printed circuit board) of the 410 power supply unit. the affected capacitors may exhibit a swelling that if not replaced, may in time cause the ventilator to shut down during normal operation. please note that should the ventilator shut down, a total power fail alarm will sound.
  • Action
    AHC Solutions is advising users to identify ventilators with serial numbers below 53164 and, using the instructions provided, identify ventilators with Power Supply Units with serial numbers between 163746 to 167558 for replacement.

Device

SLE 5000 Ventilator
  • Modèle / numéro de série
    SLE 5000 VentilatorVentilator model SLE 5000: Serial numbers below 53164Power supply unit model FP110-410: Serial numbers 163746 to 167558 inclusiveARTG Number: 114000
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd