Events

Retiro De Equipo (Recall) de LIFEPAK 20 and LIFEPAK 15 Manual Defibrillator

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
    21164
  • Fecha de inicio del evento
    2017-03-03
  • 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
    During the investigation the manufacturer of the etco2 module found that compressed air may have contaminated filters within in the etco2 module. as a result of the contamination of the filter, the etco2 display on the lifepak 15 will provide a reading of xxx. there may be solid or dashed lines present on the device display in the place of an etco2 waveform and the service led will be illuminated. in this situation the etco2 monitoring functionality will no longer be available.
  • Acción
    Product to be exchanged

Device

LIFEPAK 20 and LIFEPAK 15 Manual Defibrillator
  • Modelo / Serial
    Model: , Affected: LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option.
  • Manufacturer
    Physio-Control Corporation

Manufacturer

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