Events

Rappel de Puritan Bennett 840 Ventilator with 9.4 inch graphical user interface (GUI) assembly

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-2014-RN-00653-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-06-18
  • 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-2014-RN-00653-1
  • 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
    Covidien has received customer reports that have included the gui display screens (both upper and lower) becoming blank during use. this event interferes with the clinician’s ability to view and/or change ventilator setting or clinician-set patient alarm parameters. the ventilator continues to provide respiratory support during these events.
  • Action
    Covidien is advising that if users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability ie, confirm the patient is receiving ventilatory support by observation of the expansion and contraction of the patient’s chest and assess current patient status by review of other monitoring (e.g., oxygen saturation, heart rate, blood pressure, etc). The patient should be transferred to an alternative ventilator. Covidien will be replacing affected backlight inverter PCBAs and performing 10,000 hour preventative maintenance. This action has been closed-out on 29/01/2016.

Device

Puritan Bennett 840 Ventilator with 9.4 inch graphical user interface (GUI) assembly
  • Modèle / numéro de série
    Puritan Bennett 840 Ventilator with 9.4 inch graphical user interface (GUI) assemblyARTG Number: 182309
  • 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