Events

Retiro De Equipo (Recall) de LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Physio-Control Australia Pty Ltd.

¿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
    RC-2017-RN-00296-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00296-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    An issue has been identified where the etco2 reading on the lifepak 15 can intermittently show a value of “xxx” after start-up or during device operation. an investigation by the manufacturer of the etco2 module has revealed that compressed air may have contaminated filters within in the module. as a result of this filter contamination, the etco2 display on the device 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
    Physio-Control is advising users who experience the “XXX” after power-up or during device operation to make immediate contact to arrange for servicing of the affected device. Users are further advised that if the issue does not occur, to continue performing the daily device self-tests as indicated in the Operating Instructions and the device is safe to use.

Device

LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionality
  • Modelo / Serial
    LIFEPAK 15 Monitor/Defibrilators with End-Tidal CO2 (EtCO2) functionalityMultiple Serial NumbersEtCO2 moduleLot Codes: 1506, 1520, 1532, 1544, 1551ARTG Number: 215648
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA