Events

Rappel de Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia 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-01234-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-26
  • 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-01234-1
  • 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 spring inside the mounting latch can become dislodged causing the pdm not to latch properly resulting in an unexpected loss of patient monitoring function. this may also result in the pdm falling onto a patient or caregiver. warning messages are displayed indicating patient parameters which have been disconnected and also, a three short burst alarm is issued and repeated if acknowledged.
  • Action
    GE Healthcare is advising users to refrain from mounting the monitor above a patient or caregiver and refrain from mounting the monitor at a downward facing angle. GE Healthcare will be installing a new latch on all units once available. This action has been closed-out on 10/02/2016.

Device

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifun...
  • Modèle / numéro de série
    Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)Product Codes: SA3, SG5All monitors produced from April 2007 to December 2012.Serial Numbers: SA030713XXXXXX to SA31252XXXXXX and SG050713XXXXXX to SG51252XXXXXXARTG Number: 118982
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd