Events

Alerta De Seguridad para V60 Ventilator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Respironics California.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-08-21
  • Fecha de publicación del evento
    2012-08-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120821.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH