Events

Rappel de Puritan Bennett 840 Ventilator and 700 Series (740 and 760)

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-00093-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-24
  • 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-00093-1
  • 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
    The oxygen sensor for the ventilators has a life of one (1) year from date of manufacture of the sensor, depending on the operating conditions. conflicting information was provided to puritan bennett 840 ventilator customers in a labelling addendum stating that the oxygen sensor should be replaced every two years. if a sensor becomes non-functional during use and cannot be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied level of oxygen from the ventilator and to provide appropriate alarms. a non-functional o2 sensor does not affect the concentration of oxygen delivered from the ventilator and does not control the flow of gases.
  • Action
    Covidien is providing updated labelling to clarify the operational life of the oxygen sensor used in the Puritan Bennett 840 and 700 series ventilators. Coviden is also advising users that if a sensor becomes non-functional and facility protocol requires transfer of a patient to an alternate ventilator, the patient must be clinically evaluated to determine the best conditions for transfer to reduce risk to the patient.

Device

Puritan Bennett 840 Ventilator and 700 Series (740 and 760)
  • Modèle / numéro de série
    Puritan Bennett 840 Ventilator and 700 Series (740 and 760) Ventilators Oxygen Sensor Part Number for 840 Ventilator: 4-072214-00Oxygen Sensor Part Number for 700 Series Ventilator: G-062010-00ARTG Number: 182309
  • 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