Events

Retiro De Equipo (Recall) de Philips HeartStart MRx Monitor/Defibrillator

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Philips Medical Systems (USA).

¿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
    18144
  • Fecha de inicio del evento
    2015-03-10
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • Causa
    The mrx 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 mrx generates an entry in the status log., 3. service mode is exited., , the mrx is then in a state that could trigger a reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed. the mrx will restart within 8 seconds., note: if a reboot occurs during clinical use, current device settings and patient record are retained.
  • Acción
    Software to be upgraded

Device

Philips HeartStart MRx Monitor/Defibrillator

Manufacturer

Philips Medical Systems (USA)
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA