Events

Rappel de Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtel 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-2015-RN-00445-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-28
  • 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-2015-RN-00445-1
  • 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
    Due to a software defect the ultraview sl command module can in advertently reset. the reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. upon completion of the reset sequence, all alarm limits will be reset to their site-defined default values. critical alarms for ventricular fibrillation and asystole are always enabled after the reset. if invasive pressure is being monitored, labels will be reset to default values and the zero calibration will be lost. if non-invasive pressure is being monitored, the automatic measurement mode will be disabled.A separate failure mode can also occur where the spo2 menu keys become unresponsive and prevent user changes to spo2 operation and alarm settings. in this state, all alarm limits, alarm functions and parameter monitoring continue unaffected and all alarm limits other than spo2 can still be adjusted.
  • Action
    Medtel Pty Ltd will contact users to schedule a convenient time to correct all of the affected Ultraview SL Command Modules at no cost. This action has been closed-out on 11/08/2016.

Device

Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015
  • Modèle / numéro de série
    Ultraview SL Command Module(Patient monitoring system)Modules shipped or repaired after 8 March 2015Catalogue number: 91496ARTG number: 109585
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA