Events

Retiro De Equipo (Recall) de Hamilton/47244/Ventilators

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 Hamilton Medical AG.

¿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
    21919
  • Fecha de inicio del evento
    2017-09-04
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    The manufacturer has identified an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. after two and a half years, the battery fuel gauge may indicate a higher battery charge as to what is available. the technical failure 444001 low battery high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode.
  • Acción
    Product to be destroyed

Device

Hamilton/47244/Ventilators
  • Modelo / Serial
    Model: , Affected: Hamilton C2 and Hamilton C3
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG