Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par TRUMPF Medizin Systeme GmbH..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 004 09 17 000
  • Date de mise en oeuvre de l'événement
    2017-09-03
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11481
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    During continuous monitoring and analysis of trumpf medical products installed in the field, customers have reported that the universal arm support may be unable to hold its set position and support the arm of the patient. investigation 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, and there are no known safety risks related to it. as a reminder, the universal arm support is used to position and restrain a patient’s arm securely during surgery, as well as the induction and recovery phases.

Device

Universal Arm Support
  • Modèle / numéro de série
    Product Name Model Number up to serial number Universal Arm Support 450 1697630 103106579 Universal Arm Support 450 T 1697635 103011318 Universal Arm Support 600 1697639 102631713 Universal Arm Support 600 T 1697651 102968819 Universal Arm Support 450 U 1697660 102956866 Universal Arm Support 450 U T 1697662 102945650
  • Description du dispositif
    Arm Support
  • Manufacturer
    TRUMPF Medizin Systeme GmbH.

Manufacturer

TRUMPF Medizin Systeme GmbH.
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Représentant du fabricant
    Medical regulations gate
  • Source
    SFDA