Events

Rappel de PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2016-RN-00040-2
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-01-18
  • 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-00040-2
  • 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
    A quality issue has been identified, relating to an incorrect power status indication with the ps900 power module supplied with the affected patient monitoring products. the products with the defective power module installed can generate false "battery low" alarms, and may have an incorrect power status shown on the screen.The battery cannot be used in its current state as it cannot be recharged. however, the products can continue to be used the by plugging them into main power.
  • Action
    The sponsor is advising users that the affected devices can continue to be used provided that they are connected to a main power. The sponsor will contact the affected users to arrange for a firmware upgrade and/or the replacement of the power module. This action has been closed-out on 16/05/2017.

Device

PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors
  • Modèle / numéro de série
    PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors Product code: ED-SE-1200E-BSerial numbers of the monitors affected:60531-M1590102000160531-M1590102000260531-M1590102000360531-M1590102000560531-M1590102000960531-M1590454000260531-M1590454000311076-M1590453000111076-M1590453000211076-M1590453000311076-M1590453000411076-M15904530005ARTG Numbers: 178086 and 236697
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd