Events

Retiro De Equipo (Recall) de Resmed Astral Batteries and Battery Packs

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 ResMed (Australia) Ltd.

¿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
    20505
  • Fecha de inicio del evento
    2016-08-16
  • 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: ResMed (NZ) Ltd, 266 Runciman Road, Pukekohe, Auckland
  • Causa
    There have been a small number of occurrences (<0.1%) where an internal electrical fault has led to ventilation ceasing without either of the low battery alarms being activated. in all of these cases the total power failure alarm is activated as intended. this fault has also been reported with the astral external battery, however there have been no reports of cessation of ventilation.
  • Acción
    Product to be exchanged

Device

Resmed Astral Batteries and Battery Packs
  • Modelo / Serial
    Model: , Affected: All Astral External Batteries, All Astral battery packs
  • Manufacturer
    ResMed (Australia) Ltd

Manufacturer

ResMed (Australia) Ltd