Events

Rappel de Universal Arm Support Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Trumpf Med Aust Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00217-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00217-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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