Events

Retiro De Equipo (Recall) de Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T

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-2018-RN-00217-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-21
  • 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-2018-RN-00217-1
  • 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
    During continuous monitoring and analysis of trumpf medical products installed in the field, some customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. investigations indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. the product has not been involved with any reported injuries.
  • Acción
    Trumpf Medical is advising users to confirm all mechanical functions are parts are undamaged and in good working order prior to each use as outlined in the IFU. In cases where it is identified that the device is defective, damaged, leaking oil or will not hold its set position, stop use of the device and contact Trumpf Medical: service.au@trumpfmedical.com to receive the replacement parts. Please ensure replaced part sare returned to Trumpf Medical.

Device

Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T
  • Modelo / Serial
    Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U TModel Numbers: 1697630, 1697635, 1697639, 1697651, 1697660, & 1697662.Serial Numbers up to (respectively): 103106579, 103011318, 102631713, 102968819, 102956866, 102945650Manufactured between May 2012 and Aug 25 2016ARTG Number: 296295Trumpf Med Aust - Holder, patient, arm
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd