Events

Alerta De Seguridad para V60 Non-invasive Ventilators

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

¿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
    2013-06-20
  • Fecha de publicación del evento
    2013-06-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130620b.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 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.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH