Events

Retiro De Equipo (Recall) de HeartStart HS1 & FRx

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
    22713
  • Fecha de inicio del evento
    2018-03-13
  • 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 has become aware of a specific issue with one of the electric components (a resistor) in approximately 660,000 aeds that were manufactured between 2002-2013. virtually all of these resistor-related failures were detected through the device's automatic self-testing, alerting the user by issuing audible chirps. the in-use reliability of these aeds is greater than 99.9% when the aed determines a cardiac arrest victim is in need of shock therapy.
  • Acción
    Manufacturer to issue advice regarding use

Device

HeartStart HS1 & FRx

Manufacturer

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