Events

Retiro De Equipo (Recall) de Lithium Ion batteries used with Philips HeartStart MRx Monitor/Defibrillator

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-2014-RN-00195-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-24
  • 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-2014-RN-00195-1
  • 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
    The philips heartstart mrx monitor/defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from rf energy sources.
  • Acción
    Philips is replacing all affected batteries. In the interim Philips is advising that shut down can be avoided by operating the device on AC or external DC power or by following the actions when operating on battery power: - before placing the MRx into use, insert a fully charged battery with five solid green lights on the battery fuel gage when the fuel gauge button is pressed - If your device does not power on, press the fuel gauge button and verify that at least one solid green light is illuminated. If there are no lights, insert a fully charged MRx battery.

Device

Lithium Ion batteries used with Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Lithium Ion batteries used with Philips HeartStart MRx Monitor/DefibrillatorMRx Serial Numbers: 11327-0019-P, 11315-0032-P, 11315-0214-P, 11322-0088-P, 11315-0023-P, 11315-0033-P, 11315-0219-P, 11327-0043-P, 11315-0027-P,11315-0036-P, 11315-0391-P, 11327-0044-P, 11315-0031-P, 11315-0109-P, 11322-0084-P, 11322-0088-PARTG Number: 95661
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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