Events

Retiro De Equipo (Recall) de Philips HeartStart MRx Monitor/Defibrillator with Q-CPR

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-00196-1
  • 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-00196-1
  • 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
    When the heartstart mrx is in aed mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘do not touch the patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete.When the heartstart mrx is in manual mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter ‘do not touch the patient” icon may incorrectly remain on the screen after shock delivery is complete.Due to incorrect cpr instructions, the clinician may follow the 'do not touch the patient command on the q-cpr meter and may not resume chest compressions in a timely manner resulting in a delay in the delivery of cpr.
  • Acción
    A software upgrade will be provided to customers with affected devices. Customers are advised to use their HeartStart MRx without the Q-CPR meter attached. If customers choose to use the HeartStart MRx with the Q-CPR meter attached and they observe that the Q-CPR meter is displaying the 'Do Not Touch The Patient' icon at an unexpected time, follow the MRx Instructions For Use and remove the eter from the patient and continue CPR according to their organization's protocol.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
  • Modelo / Serial
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRUnits Affected: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587ARTG 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