Events

Retiro De Equipo (Recall) de Physio-Control Lifepak 1000 Defibrillators

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 Physio-Control Corporation.

¿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
    21045
  • Fecha de inicio del evento
    2017-02-03
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Causa
    Reports of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly during patient treatment. this unexpected shut down is due to an intermittent connection between the battery and device contacts, the company has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration and have a battery installed for long periods of time. this issue can potentially affect any lifepak 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible to this issue.
  • Acción
    Manufacturer to issue advice regarding use

Device

Physio-Control Lifepak 1000 Defibrillators

Manufacturer

Physio-Control Corporation
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA