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
    42948
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-16
  • 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 that the heartstart mrx defibrillator/monitor could reboot once in any operating mode if the following sequence occurs: 1. in service mode the status log* is cleared 2. prior to exiting service mode the device generates an entry in the status log. 3. service mode is exited. the heartstart mrx device is then in a state that could trigger a reboot at an indeterminate time potentially causing therapy to be interrupted or delayed. the heartstart mrx device will restart within 8 seconds. note: if a reboot occurs during clinical use current device settings and patient record are retained. *the status log is a tool accessed by service personnel. it includes entries for all messages logged during normal operating mode automated tests service and configuration mode and operational checks. the heartstart mrx defibrillator/monitor service manual instructs service personnel to clear the status log after successful completion of an operational check.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Modelo / Serial
    Model Catalog: M3536A (Lot serial: FOR MODEL M3536A:); Model Catalog: M3535A (Lot serial: FOR MODEL M3536A:); Model Catalog: M3535A (Lot serial: FOR MODEL M3535A:); Model Catalog: M3536A (Lot serial: US00100100 to US00578696); Model Catalog: M3535A (Lot serial: US00100100 to US00578696); Model Catalog: M3535A (Lot serial: US00100902 to US00576650); Model Catalog: M3536A (Lot serial: US00100902 to US00576650); Model Catalog: M3536A (Lot serial: FOR MODEL M3535A:)
  • 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