Events

Retiro De Equipo (Recall) de CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare 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-00873-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-20
  • 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-00873-1
  • 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
    Ge healthcare observed during a pre-installation checkout procedure that an impedance respiration apnea alarm could not be produced with pdm v2.6 and carescape b850 v 2.0.7 host monitor software. the pdm v2.6 has been limited to a small number of customer sites. the issue was identified in the biomed shop during check out. to date, no actual reported patient incidents of a missed apnea alarm with pdm v.2.6 have been reported.
  • Acción
    GE Healthcare will correct all affected products at no cost to users. A GE Healthcare representative will contact each affected site to arrange for the correction to take place.

Device

CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 an...
  • Modelo / Serial
    CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)ARTG Number 118982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd