Events

Retiro De Equipo (Recall) de Welch Allyn Propaq LT/ Propaq 802 Patient Monitor

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 Welch Allyn Protocol Inc.

¿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
    15629
  • Fecha de inicio del evento
    2013-11-15
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Causa
    Internal serial testing has identified fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this were to occur the device would either present an error screen instructing the user to restart the monitor, or could present a blank screen or white screen.Either screen would be accompanied by one or more blimking led lights, and in either case, the isue would be resolved by restarting (power cycling) the monitor.
  • Acción
    Software to be upgraded

Device

Welch Allyn Propaq LT/ Propaq 802 Patient Monitor

Manufacturer

Welch Allyn Protocol Inc