Alerte De Sécurité sur trilogy 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 Philips Healthcare.

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
    2014-02-19
  • Date de publication de l'événement
    2014-02-19
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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: philips trilogy ventilators medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning trilogy ventilators with model numbers t100, t200 and t202, shipped between 31 december 2013 and 30 january 2014. the affected ventilators may contain a potentially defective component on the power management board which could affect the function of the trilogy ventilator. in the worst case scenario, failure of this component could result in loss of therapy with reduced alarm functionality. loss of therapy for a patient on ventilator for life support could result in serious injury or death. according to the manufacturer, there have been no reports of death or serious injury related to this potential problem. the manufacturer advises customers to quarantine all affected devices, retrieve affected devices in use and replace them with an unaffected trilogy ventilator. customers are advised to return all affected devices to the manufacturer who will arrange replacement of the products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2014.

Device

Manufacturer

  • Société-mère du fabricant (2017)
  • Source
    DH