Events

Rappel de Puritan Bennett 980 Series Ventilator System PB980

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien 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-00089-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-02-03
  • 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-00089-1
  • 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
    There have been reports of issues with the graphical user interface (gui) & loss of primary ventilation. the gui can become unresponsive to touch, but the ventilator continues to operate at existing settings, all real-time waveforms, pressure/volume measurements, alarm functions & the bezel keys remain active. however, users are unable to change ventilator settings/configuration of the display. plus, under certain circumstances there is a loss of primary ventilation capabilities, in which the backup ventilation (buv) design feature is activated. when buv is initiated, high urgency audio & visual alarms are enunciated immediately & cannot be silenced. in some cases, the ventilator subsequently progressed to a ventilator inoperative condition, where the ventilator opens all valves to atmospheric pressure & room air, & ventilation ceases. high urgency audio/visual alarms are enunciated. there have been no reports of adverse health effects or death associated with the above situations.
  • Action
    Covidien is advising users that the continued use of the affected devices is appropriate. However, the decision to continue to use the affected devices should be made in the context of the individual patient’s clinical condition. If the reported defects occur, the clinical team should transfer the patient to anther ventilator. The manufacturer is working on a service update which will be implemented as soon as it becomes available.

Device

Puritan Bennett 980 Series Ventilator System PB980
  • Modèle / numéro de série
    Puritan Bennett 980 Series Ventilator System PB980All models affectedARTG Number: 221416
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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