Events

Retiro De Equipo (Recall) de Infant Warmer System (IWS)

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-2016-RN-01189-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-13
  • 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-2016-RN-01189-1
  • 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 has recently become aware of a potential safety issue related to loose screws in the “heater head” of certain infant warmer system (iws) devices. hot screws from the “heater head” of the iws could fall onto the bed if the “heater head” assembly has been improperly serviced. this could result in thermal injury to a patient. to date, two injuries have been reported as a result of this issue.
  • Acción
    GE Healthcare is providing users with interim instructions to check the screws on the "Heater Head" are tight. This will form part of the annual Preventative Maintenance check to ensure the screws are tightened. This action has been closed-out on 23/05/2017.

Device

Infant Warmer System (IWS)
  • Modelo / Serial
    Infant Warmer System (IWS)Model Numbers: 3000 IWS, 3300 IWS, 3400 IWS and 4400 IWSARTG Number: 139290
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd