Events

Alerte De Sécurité sur V60 Non-invasive Ventilators

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Respironics California Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-06-20
  • Date de publication de l'événement
    2013-06-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130620b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: respironics v60 non-invasive ventilators the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning v60 non-invasive ventilators which is manufactured by respironics california inc., a division of philips healthcare. in the rare even a component fails due to a software issue, the following sequence of events may occur: power management board assembly vmain shorts to ground, the ventilator shuts down, the software repeatedly cycles through part of its initialisation sequence and power on self test, the alarm may not sound to indicate that ventilation therapy has ceased. the manufacturer advises user that the v60 ventilator may continue to be used in accordance with its directions for use. the manufacturer will contact users to schedule the corrective action to upgrade the software. a loan unit will be provided to the users until the corrective action is completed. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00625-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2013.

Device

V60 Non-invasive Ventilators

Manufacturer

Respironics California Inc.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH