BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF TABLE TOP FRAME

    MDR report key: 7278192 · Received February 16, 2018

    Report

    Report Number
    3010216206-2018-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 18, 2018
    Report Date
    January 18, 2018
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING SHOWS THAT WHEN THE TRUMPF TABLE TOP RAIL SECTION CLAMP (F-T3RAILSC) IS USED TO SUPPORT THE TRUMPF TABLE TOP LEG SUPPORT, THE WEIGHT OF THE LEG MAY EXCEED THE CAPACITY OF THE TRUMPF TABLE TOP RAIL SECTION CLAMPS RESULTING IN A LOSS OF STRUCTURAL INTEGRITY. AS AN INDIVIDUAL COMPONENT, THE TRUMPF TABLE TOP RAIL SECTION CLAMP WAS NOT DESIGNED TO BE USED AS A TRUMPF TABLE TOP LEG SUPPORT CLAMP AND IS LABELED ¿FOR USE WITH ARMBOARDS ONLY¿. THE ROOT CAUSE FOR INCORRECT INSTALLATION IS THE INSTRUCTION FOR USE(IFU) D-720595, REV A3, PAGE 6 INCORRECTLY IDENTIFIES THAT THE TRUMPF TABLE TOP RAIL SECTION CLAMP CAN BE USED TO SUPPORT A TRUMPF TABLE TOP LEG SUPPORT ASSEMBLY. THE FIELD ACTION IS IN PROCESS OF BEING INITIATED AND CLASSIFIED.

    Description of Event or Problem · 1

    ALLEN MEDICAL RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT WAS POSITIONED ON A T3 PRONE TRUMPF TABLE WITH LOWER LEGS ON DETACHABLE FOOTBOARD. AFTER THE PATIENT WAS DRAPED AND SURGEON BEGAN EXPOSING, THE FOOTBOARD FELL DOWN AND UPLIFTED FROM WHERE IT WAS ATTACHED TO THE FRAME. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122268 TRUMPF TABLE TOP FRAME TABLE TOP SPINE FRAME FWZ ALLEN MEDICAL SYSTEMS F-T3RAILSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other