Events

Rappel de AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fisher & Paykel Healthcare 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-00729-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-06-08
  • 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-00729-1
  • 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
    Fisher & paykel has updated the airvo 2 / myairvo 2 user instructions to include a check that the speaker is audible prior to each patient use in order to ensure the speaker is functioning.
  • Action
    Fisher & Paykel are advising users that the AIRVO 2 / myAIRVO 2 User Instructions have been updated to include a warning for the user to check speaker functionality before each patient use, using the steps in the User Instructions. First turn the unit on and then remove the heated breathing tube. The user should see the “check tube” visual signal and hear the speaker signal. If either signal is absent, users are advised not to use the unit and contact their Fisher & Paykel representative to arrange for a replacement device.

Device

AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier
  • Modèle / numéro de série
    AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 HumidifierModel Number: PT101XXmyAIRVO 2 HumidifierModel Number: PT100XXAffected Serial Numbers: 120521YYYYYY – 160605YYYYYYARTG Number: 177298
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd