Events

Rappel de Progressa Bed System with European (OIML) Version ScaleAll Progressa Beds manufactured prior to 16 May 2016 containing European (OIML) Version Scale

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-2016-RN-00941-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-22
  • 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-00941-1
  • 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 software issue with some progressa beds equipped with the european (oiml) version scale. the issue affects how the air system utilises data from the scale to set bladder pressure points. if the software does not convert the patient weight to the air system correctly, then in some cases the pressure setting of the bladders may be higher or lower than the optimal pressure range. in some cases, patients that are already high risk may become more susceptible to pressure ulcers. this issue does not affect the accuracy or calibration of the progressa scale weighing function. the likelihood of occurrence is less than 57/100,000 units.
  • Action
    Hill-Rom will be providing an upgrade to the software of the affected units. The upgrade allows for improved scale communications with the surface and system software, and will not affect how the scale and bed are operated. In the interim, Progressa beds equipped with the European (OIML) Version Scale may continue to be used while maintaining proper patient positioning practices.

Device

Progressa Bed System with European (OIML) Version ScaleAll Progressa Beds manufactured prior to 1...
  • Modèle / numéro de série
    Progressa Bed System with European (OIML) Version ScaleAll Progressa Beds manufactured prior to 16 May 2016 containing European (OIML) Version ScaleModel Number: P7500Serial Numbers: S1 12234946, S1 11791226 and O277AW0635ARTG Number: 221346
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd