Events

Retiro De Equipo (Recall) de Philips Xper Flex Cardio Physiomonitoring System

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 Invivo, a division of Philips Medical Systems.

¿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
    23017
  • Fecha de inicio del evento
    2018-05-24
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    A problem has been detected in the xper flex cardio patient monitoring system, it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:, 1. boom monitor (display) may not display all active waveform and/or vital sign data., 2. delayed audible and visual alarms at the flex cardio and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the flex cardio/boom monitor., 3. after patient admission and case initiation at the host system, the case may not be fully transmitted to the flex cardio.
  • Acción
    Instructions for use to be updated

Device

Philips Xper Flex Cardio Physiomonitoring System

Manufacturer

Invivo, a division of Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA