Events

Retiro De Equipo (Recall) de Hamilton G5 and S1 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
    18172
  • Fecha de inicio del evento
    2015-03-04
  • 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 received reports of the ventilator display feezing. in these cases, the red alarm lamp on top of the ventilator monitor blinks and a high-priority audible alarm is triggered, but no alarm message is displayed. the patient's ventilation continues but the screen is no longer updated and the user can no longer operate the device.
  • Acción
    Software to be upgraded

Device

Hamilton G5 and S1 Ventilators
  • Modelo / Serial
    Model: Product Code: HL-159001, Affected: , Software version: between V2.40 and V2.41
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG