Events

Retiro De Equipo (Recall) de BiPAP A 40 Ventilatory Support System; Detachable Battery Module, USA/INTL

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-01438-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-11-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01438-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Philips respironics has identified an issue where a non-conforming part (side panel) was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module (part number 109677). the issue results in the inability to connect the bipap a40 device to the detachable battery module during setup before putting the ventilator into operation on a user; therefore, there is no safety risk to the patient. the impacted bipap a40 units continue to work properly in configurations without the detachable battery module. a non-conforming part was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module.
  • Acción
    1. Complete the inspection of the devices for the potentially faulty side panel per the inspection instructions provided with the letter. 2. Complete and return Business Reply Form (BRF) and list the total quantity inspected, the quantity of correct devices, and the quantity of incorrect devices. 3. Contact your local Customer Service who will provide direction on how to return your device(s) for any confirmed faulty side panel replacement.

Device

BiPAP A 40 Ventilatory Support System; Detachable Battery Module, USA/INTL
  • Modelo / Serial
    BiPAP A 40 Ventilatory Support SystemProduct code: 1111171Detachable Battery Module, USA/INTLProduct code: 1096770ARTG number: 200289
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA