Events

Retiro De Equipo (Recall) de Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Trumpf Med Aust 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-2015-RN-00590-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-02
  • 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-2015-RN-00590-1
  • 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
    Trumpf medical has been notified of an incident where a motorised height-adjustable arm of a klinoport ceiling supply unit suddenly and abruptly fell to its lowest position. the cause analysis revealed that the welded connections of the drive did not comply with the specified condition and therefore led to breakage of these connections. it is currently not to be ruled out that further drives within the same serial numbers range may have the same fault. if further cases should occur, the risk of severe injury to persons cannot be ruled out.
  • Acción
    Trumpf Medical will replace all potentially affected components in order to prevent a repetition of this incident. Until the correction can be made end users are advised to ensure that the unit is in the lowest position. Trumpf is recommending that a warning be placed on the device or the electrical fuse removed to ensure that the height of the arm is not adjusted. This action has been closed-out on 08/08/2016.

Device

Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M
  • Modelo / Serial
    Ceiling Supply Unit klinoPORTklinoPORT 706 M, 806 M, 906 M , 1006 M, 1306MItem Numbers: 4027210, 4027410 and 4027510Serial Numbers: 100775185 to 101040245Only motorised height-adjustable arms are affected by this recall (recognisable by the letter "M" in the product name)
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd