Events

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

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by TRUMPF Medizin Systeme GmbH..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 004 09 17 000
  • Event Initiated Date
    2017-09-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11481
  • Notes / Alerts
    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.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    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
  • Model / Serial
    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
  • Product Description
    Arm Support
  • Manufacturer
    TRUMPF Medizin Systeme GmbH.

Manufacturer

TRUMPF Medizin Systeme GmbH.
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Manufacturers representative
    Medical regulations gate
  • Source
    SFDA