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-2017-RN-00401-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-03-27
  • 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-00401-1
  • 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 possibility of abnormal device behaviours has been identified in the heartstart mrx monitor/defibrillator. the device may exhibit the following issues:1. if the battery connecting pins (in the battery compartment of the heartstart mrx monitor/defibrillator) become damaged or contaminated, it could result in a poor electrical connection that may cause the mrx to either (i) not power on or (ii) repetitively reboot, when used on battery power only 2. after unplugging the device from ac mains, there are two abnormal behaviours of the heartstart mrx monitor/defibrillator that may occur:a) after the user depresses the charge button, the device attempts to charge, and after approximately 20 seconds, generates the “shock equipment malfunction” error message and is unable to deliver shock therapy.B) pacing may cease without warning. these device behaviours continue until the unit is reset.Either problem could potentially delay monitoring or therapy.
  • Acción
    Philips is advising customers to take the following corrective actions: Issue 1, inspect the HeartStart MRx battery compartment connections on the device. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue; and Issue 2, if the External Power Indicator light above the MRx display remains illuminated after the device is unplugged from AC mains power, leave the device unplugged, remove and reinsert the battery and confirm that the Indicator has turned off. Customers are requested to refer to their recall notification letter for further important details.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
    Philips HeartStart MRx Monitor/DefibrillatorModel Numbers: M3535A, M3536A, and military bundles Units: M3535A (M3535ATZ)M3536A (M3536ATZ)M3536M, M3536MCM3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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