BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBESTAND

    MDR report key: 164734 · Received April 27, 1998

    Report

    Report Number
    2424102-1998-00002
    Event Type
    Malfunction
    Date Received
    April 27, 1998
    Date of Event
    April 22, 1998
    Report Date
    April 27, 1998
    Manufacturer
    TREX MEDICAL CORP. BENNETT DIVISION
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTED THAT THE COUNTERWEIGHT IN FST-10 FELL DUE TO IMPROPER CRIMPING OF LOOPS IN COUNTERWEIGHT CABLES. AS A RESULT OF WHICH TUBE AND COLLAR ASSEMBLIES HIT THE FLOOR DURING INSTALLATION AND DAMAGED TUBE, TUBE STAND AND BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBESTAND RADIOGRAPHIC DEVICE IYB TREX MEDICAL CORP. BENNETT DIVISION FST-10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other