Events

Alerte De Sécurité sur V60 Ventilator

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.

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
    2012-08-21
  • Date de publication de l'événement
    2012-08-21
  • 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_20120821.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 ventilator the medicines and healthcare products regulatory agency (mhra), united kingdom and the health canada have posted a medical device safety alert concerning respironics v60 ventilator which is manufactured by respironics california, inc., a division of philips healthcare. a review of manufacturing data found that certain blower motor assemblies in the v60 ventilators may not meet specifications. specifically, the impeller may not be properly seated on the blower motor shaft. this could subsequently cause the blower to cease functioning which would result in the failure of the v60 ventilator to deliver therapy to the patient due to the loss of ventilation. the v60 ventilator will alert users to malfunctioning blowers by annunciating audible and visual alarms. this manufacturing issue has been corrected. philips has received two reports of blower motor failures in v60 ventilators to date. while there have been no reports of patient injury, respironics california, inc. is replacing all affected blower motors that may have improperly-seated impellers on its v60 ventilators. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ index.Htm, and the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 august 2012.

Device

V60 Ventilator

Manufacturer

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