Events

Retiro De Equipo (Recall) de HeartStart MRx External Defibrillator (AED)

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
    22606
  • Fecha de inicio del evento
    2018-02-13
  • 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
    The manufacturer is advising all customer, 1. to ensure heartstart mrx customers have access to the heartstart mrx addendum as a supplement to the mrx instructions for use (ifu), 2. to ensure heartstart fr3 customers whose q-cpr meters are used on an mrx are aware that certain information contained in the fr3 aed instructions for administrators (ifa) and the fr3 q-cpr meter instructions for use (ifu) also applies to use of the q-cp meters with the mrx.
  • Acción
    Instructions for use to be updated

Device

HeartStart MRx External Defibrillator (AED)

Manufacturer

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