Events

Retiro De Equipo (Recall) de Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz Controllers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hill-Rom 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-01388-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-06
  • 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-01388-1
  • 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
    Hill-rom has become aware of a potential issue with some international (220 - 240 v, 50 hz) compella air surfaces. within the low air loss mattress, a hose in the foot section is prone to kinking and occluding air flow. this can result in heat rising and failure of the air compressor inside the compella controller. if the compressor fails, the controller can no longer function correctly to maintain air flow to the compella mattress, in which case the controller will alarm. to date, there have been no reported patient safety related complaints associated with this issue.
  • Acción
    Hill-Rom is advising users that the affected systems will be corrected as a permanent fix. The systems can continue to be used until the correction has been completed.

Device

Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220...
  • Modelo / Serial
    Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz ControllersSerial Numbers: CR600003 to CR604302 and CU200002 to CU200072Manufacturing date range is from March 2015 – March 2017 ARTG Numbers: 239273 and 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd