Events

Retiro De Equipo (Recall) de Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits

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-00143-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-02-04
  • 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-00143-1
  • 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 with the btv switch of certain carestation 600 series anaesthesia systems. the btv switch could become difficult to move between mechanical ventilation and manual bag modes or remain in a position where it is not possible to ventilate the patient using the anaesthesia system. this issue could result in loss of patient ventilation potentially resulting in hypoxia. there have been no customer complaints or injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising users that the systems can continued to be used. However users should ensure back up ventilation, independent of the anaesthesia machine is available. GE is advising users all affected devices will be corrected.

Device

Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits
  • Modelo / Serial
    Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kitsSerial Numbers: Carestation 620 A1 (GTIN: 00840682103985): SM615020004WA to SM616010008WACarestation 650 A1 (GTIN: 00840682103947): SM715020005WA to SM716010008WACarestation 650c A1 (GTIN: 00840682103954): SM815020001WA to SM815500001WAService kits affected2071003-001-S , BTV SWITCH ASSEMBLY2081000-001-S , ASSY BOTTOM BC2082466-001-S, ASSY BOTTOM BC AUS FEMALE 22ARTG Number: 93955
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd