Events

Retiro De Equipo (Recall) de Philips V60 non-invasive ventilatorAll ventilators with a date of manufacture prior to15 September 2015

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-00650-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-23
  • 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-00650-1
  • 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 has identified an issue with an internal cable of the philips v60 non-invasive ventilator manufactured prior to 15 september 2015. over time, low-frequency vibrations can cause the pins within the female connectors on the internal motor controller to data acquisition board ribbon cable to become partially displaced, which causes momentary high resistance that interferes with data transfer. this may cause the ventilator to fail power on self testing (post) or cause continuous built in test (cbit) to detect a fault and lead to a ventilator shut down with alarm during use or during intra-hospital transport.If a vent inop event occurs when a patient is connected, pressure support and o2 delivery will cease. such cessation may cause the patient’s spo2 to drop and, if the alarm is not attended to promptly, may lead to hypoxemia or hypercarbia.There have been two reported deaths and nine reports of harm/injury from overseas jurisdictions.
  • Acción
    To minimise risks of illness or injury, users are requested to operate the V60 as directed or recommended in the operator’s manual, including by: · Promptly attending to all alarms presented by the V60 Ventilator; · Using an external O2 monitor/analyser and setting the alarm thresholds appropriately; · Ensuring the correct circuits and masks identified in the operator’s manual are used with the V60; · Wherever possible, connecting the V60 to a remote call system; and If the V60 Shuts down, alarms, and displays any of the error codes 100A, 1006, 1007, or 1008, then (i) turn the V60 off, (ii) discontinue use of the V60, and (iii) use an alternate ventilator. Call your local customer service contact and report the failure. Please reference FCO86600037A. The incidence of failure is low but there is significant risk if it occurs. In deciding whether to continue using the V60, facilities should consider their monitoring and response capabilities or an alternative ventilator.

Device

Philips V60 non-invasive ventilatorAll ventilators with a date of manufacture prior to15 Septembe...

Manufacturer

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