BEUDAMED
    FDA Adverse Event Summary report: N

    TREX

    MDR report key: 288796 · Received July 31, 2000

    Report

    Report Number
    288796
    Date Received
    July 31, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 14, 2000
    Manufacturer
    TREX MEDICAL CORP.
    Product Code
    JAA
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SPOT FILM TOWER MALFUNCTIONED AND BUMPED INTO PT. THE TOWER FAILED TO MOVE PROPERLY AND STARTED A JERKY MOTION. THE UNIT HAD BEEN WORKED ON LESS THEN ONE WEEK BEFORE BY DISTRIBUTOR. THE DRS REFUSE TO USE THE EQUIPMENT ANY LONGER, THEY FEEL IT IS UNSAFE FOR USE ON PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREX ROD AND FLORAL UNIT JAA TREX MEDICAL CORP. 6626-212A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *