BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIAD XLT

    MDR report key: 62352 · Received January 13, 1997

    Report

    Report Number
    1527587-1997-00001
    Event Type
    Malfunction
    Date Received
    January 13, 1997
    Date of Event
    January 3, 1997
    Report Date
    January 9, 1997
    Manufacturer
    TRIONIX RESEARCH LABORATORY, INC.
    Product Code
    JWM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE 67 YEAR OLD MALE WAS BEING SCANNED, HEAD 2 DETECTOR DROPPED AND TOUCHED PT, PT WAS EXAMINED AT THE HOSP, NO INJURIES WERE FOUND. APPARENTLY THE RADIUS BALL SCREW BROKE AT THE JUNCTION OF THE MOTOR, ALLOWING THE DETECTOR TO DROP DOWNWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIAD XLT NUCLEAR DIAGNOSTIC IMAGING CAMERA JWM TRIONIX RESEARCH LABORATORY, INC. BIAD XLT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other