Events

Retiro De Equipo (Recall) de Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.

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-2015-RN-00832-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-08-28
  • 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-2015-RN-00832-1
  • 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
    Adhesive pads:during internal review, philips identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. patient chest injury:instructions did not inform the users that properly performed cpr can result in injuries to the patient.
  • Acción
    Philips has updated the HeartStart MRx’s Instructions for Use associated with Q-CPR meter and CPR sensor via an addendum. The addendum has instructions on application of the disposable adhesive pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and orientation of this pad. In addition, the addendum includes general information on the types of injuries, which may occur during CPR. This action has been closed-out on 24/08/2016.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and ...
  • Modelo / Serial
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRAFFECTED PRODUCTSProduct: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.Units Affected: All Q-CPR meter and CPR sensor, models 453564145481, 453564257691, and M4761A are affected.ARTG: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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