Events

Rappel de Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators

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-2017-RN-01429-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-22
  • 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-2017-RN-01429-1
  • 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
    Medtronic has identified specific units of lithium ion batteries which are used in puritan bennett 980 ventilators, following reports that the batteries may not fully charge after installation. the scope of this notice includes batteries that were manufactured between december 2013 and may 2017, with serial numbers begin with 1201xxxxxx through 1712xxxxxxa functional battery installed in the pb980 ventilator automatically recharges when the battery depletes and the ventilator is connected to ac power. in the case of a battery with incorrect firmware, it may fail to fully charge. this situation does not impact the ventilator’s operation when it is connected to ac power. however, if the ventilator is operated on battery power alone, this situation could limit the amount of time the ventilator is operational.
  • Action
    Notify all care environments in which the PB980 ventilators are used about this notification. If PB980 ventilators have been distributed to other persons or facilities, promptly forward a copy of this letter to them. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Medtronic service engineers will inspect batteries in the field during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced. The PB980 ventilator may continue to be used as described in the Operator’s Manual.

Device

Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators
  • Modèle / numéro de série
    Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 VentilatorsProduct Code: 10086042Serial Numbers beginning with 1201xxxxx through 1712xxxxxxARTG Number: 221452
  • 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