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
    65943
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-13
  • 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
    The philips heartstart mrx monitor/defibrillator can deliver a non-synchronized shock in the synchronized cardioversion mode as follows: this rare condition can occur if the specific steps for delivering a synchronized shock in the heartstart mrx instructions for use are not followed. if the user rotates the therapy knob while simultaneously pressing the sync button then charges the mrx and presses the shock button the mrx could deliver a non-synchronized shock. the mrx will still display r wave markers as if normally operating in synchronized cardioversion mode. the "sync" label will still be seen on the display. when the mrx is charged and the shock button pressed the shock will be immediately delivered and may not be synchronized to the r wave. in addition the label affixed to the top of the mrx device is not consistent with the mrx instructions for use on synchronized cardioversion.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modelo / Serial
    Model Catalog: M3536A (Lot serial: >1000 numbers contact mfg); Model Catalog: M3535A (Lot serial: >1000 numbers contact mfg)
  • 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