Events

Retiro De Equipo (Recall) de Philips Heartstart XL+ Defibrillator/ 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 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
    16159
  • Fecha de inicio del evento
    2014-02-07
  • 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
    We have discovered through customer feedback and internal testing that the heartstart xl+ battery charge time to 100% capacity at 35°c (95°f) is slightly longer than the specified 3 hour duration stated in the existing product labelling. since the xl+ can operate with a partially charged battery, there is no patient risk associated with a longer battery charge time.
  • Acción
    Instructions for use to be updated

Device

Philips Heartstart XL+ Defibrillator/ Monitor

Manufacturer

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