Events

Retiro De Equipo (Recall) de LifePoint bPLUS

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 Metsis Medikal Ltd Sti.

¿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
    21574
  • Fecha de inicio del evento
    2017-06-22
  • 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: Total Safety Solutions Ltd, 19 Bridgehead Cove, Hobsonville, Auckland 0618
  • Causa
    As a result of the momentary communication interruption caused by the software of automatic external defibrillator devices during the self-test procedure, the device got stuck in stand-by during this process and the bios battery was depleted then the device was locked-up due to processor being subjected to low supply voltage during depletion of bios battery and the warning indicator was stuck in green, not switching to red by full depletion of bios battery. the self-test is performed by the main processor and cannot control the indicator position in the event of possible instantaneous communication and lockup problems.
  • Acción
    Software to be upgraded

Device

LifePoint bPLUS
  • Modelo / Serial
    Model: , Affected: Models: LifePoint Pro, LifePoint bPLUS, LifePoint mPLUS
  • Manufacturer
    Metsis Medikal Ltd Sti

Manufacturer

Metsis Medikal Ltd Sti