Events

Rappel de Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Welch Allyn Australia Pty Limited.

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-01124-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-08
  • 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-01124-1
  • 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
    Internal product testing conducted by welch allyn has identified fault conditions relating to electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this event were to occur, the device would either present an error screen instructing the user to restart the monitor, or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights, and in either case, the issue would be resolved by restarting (power cycling) the monitor. this issue is more likely to occur at higher energies such as 5kv. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.
  • Action
    Welch Allyn is providing work around instructions for users to follow if the error messages are displayed. A software update will be implemented to permanently correct the issue.

Device

Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)
  • Modèle / numéro de série
    Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)Model Numbers: 802LTAN, 802LT0NSerial Numbers: KA009946 to KA027084 and KL014918 to KL019440ARTG Number: 123809
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited