BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREX MEDICAL CORP.

    MDR report key: 288802 · Received July 31, 2000

    Report

    Report Number
    288802
    Event Type
    Malfunction
    Date Received
    July 31, 2000
    Date of Event
    July 27, 2000
    Report Date
    July 28, 2000
    Manufacturer
    TREX MEDICAL CORP.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A FLUORO TOWER TO A TREX X-RAY SYSTEM BECAME UNCONTROLLABLE DURING A MYELOGRAM. TOWER COULD NOT BE PLACED OVER AREA OF INTEREST TO OBTAIN THE DAMAGE. THE TOWER WOULD OSCILLATE BACK AND FOURTH. THE UNIT WAS UNCONTROLLABLE. THERE WAS NO INJURY TO THE PT. HOWEVER IT WAS UNSAFE TO USE AND WAS SHUT DOWN. HOSP FELT THAT THEY PUT THE PT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREX MEDICAL CORP. ROD AND FLUORO UNIT JAA TREX MEDICAL CORP. 6806-126 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR