Events

Retiro De Equipo (Recall) de 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-00187-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-21
  • 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-00187-1
  • 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
    A component of the mrx processor board may be susceptible to damage from electrostatic discharge (esd). damage to these components can disrupt ecg and spo2 functionality leading to an inability to perform:- demand mode pacing- 12 lead ecg acquisition and analysis- ecg monitoring via leads- pulse oximetry (spo2)the presence of this condition will be displayed on the ready for use (rfu) indicator as a solid red x with periodic audio chirp.
  • Acción
    A hardware upgrade will be provided to correct the issue. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. Philips is also advising users to immediately contact their Philips authorised service personnel if it is observed that the MRx is displaying a solid red ‘X’ in the RFU indicator and displaying the 'ECG Equip Malfunction' INOP, a failure that may disable some ECG and SpO2 functionality.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers M3535A, M3536A, M3536J, M3536MCSerial numbers within the following ranges:Model M3535A: US00100100 to US00541372Model M3536A: US00100902 to US00541375Model M3536J: US00209838 to US00332675Model M3536MC: US00500001 to US00500020 ARTG 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