Events

Retiro De Equipo (Recall) de HEARTSTART MRX DEFIBRILLATOR/MONITOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS 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
    43736
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-02-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Philips has become aware of the following issues regarding the heartstart mrx monitor/defibrillator: 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.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modelo / Serial
    Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL); Model Catalog: 861444 (Lot serial: ALL)
  • Descripción del producto
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC