Events

Rappel de Sara Combilizer (patient transfer lift)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Huntleigh Healthcare 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-2016-RN-00911-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-11
  • 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-2016-RN-00911-1
  • 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
    It has been identified that a tipping hazard may occur on the current sara combilizer lifting mechanism, resulting in a potential risk to the patient or caregiver. the tipping hazard may occur when fully loaded sara combilizer in “stretcher mode” is lifted to the highest position (approximately 984 mm ˜ 38 3/4”) and tilted backwards to the angle of 25°-28°. this scenario has been defined as highly unlikely to occur during use with patients.
  • Action
    Huntleigh Healthcare is arranging for an upgrade to the Sara Combilizer that involves the replacement of two parts of the lifting mechanism to ensure the device full stability. In the interim, Huntleigh Healthcare is advising users that the Combilizer can continue to be used until the upgrade is performed, on the condition that the tilt angle in the device "stretcher mode" will be no greater than 15° and the device is not loaded over 330 lbs (150 kg). An Addendum to the Instruction For Use that includes directions to ensure patient safety is also being provided to users. This action has been closed-out on 11/05/2017.

Device

Sara Combilizer (patient transfer lift)
  • Modèle / numéro de série
    Sara Combilizer (patient transfer lift)Model Number: APA1000 Serial Numbers: P0299662, P0325930, P0325931 & P0325933Manufactured between 16 May 2014 & 17 March 2016ARTG Number: 199602
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA