Events

Rappel de CareFusion - AVEA Ventilator

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia 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-2015-RN-00433-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-21
  • 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-2015-RN-00433-1
  • 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
    When the avea ventilator develops a malfunction of the pressure transducer in the ventilator that measures the inspiratory or expiratory pressure of the circuit, a false alarm is initiated indicating an extended high ppeak or circuit occlusion depending on the specific failure mode within the pressure transducer. most reports of ext high ppeak or circuit occlusion alarms have been detected prior to use of the ventilator on a patient. if a malfunction occurs, a delay of initiation of ventilation may result. under these circumstances, the ventilator by design will alarm and cease ventilation. the safety valve will open allowing patients that can spontaneously breathe to do so. the reported rate of occurrence is very low with no reports of patient injury received to-date.
  • Action
    Customers are advised that they will be contacted by a Device Technologies representative to arrange for onsite remediation of the affected devices, in the interim if any AVEA ventilator unit exhibits a sustained Ext High Ppeak or Circuit Occlusion alarm followed by the opening of the Safety Valve, that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact Device Technologies Technical Support.

Device

CareFusion - AVEA Ventilator

Manufacturer

Device Technologies Australia Pty Ltd