Events

Rappel de NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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-00247-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-03-08
  • 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-2016-RN-00247-1
  • 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
    Two laptops returned from medtronic japan distribution centre alleged a power supply issue. the defective power supply could impact the performance of the gui by introducing latency (delay) in its performance. however, once the units are turned on while connected to their respective power supplies (dell 90 watt ac adapters), the users would be warned by the "ac alert message" that is shown on the screen during the boot up process. this issue is unlikely to present a hazard to either the patient or the user. there have been no complaints or adverse events reported for this issue from the field.
  • Action
    Medtronic will replace the affected power supply units with unaffected stock. This action has been closed-out on 27/01/2017.

Device

NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular mon...
  • Modèle / numéro de série
    NIM-ECLIPSE Notebook Computer, NCCPU-E4(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)Lot / Batch numbers: X06016674, X06016675, X06018893, X06026959,X06026960, X06026961, X06026962, X06026963,X06040001, X06040002, X06042171, X06042172,ARTG number: 169810
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA