BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE

    MDR report key: 299034 · Received September 28, 2000

    Report

    Report Number
    2916556-2000-00342
    Event Type
    Malfunction
    Date Received
    September 28, 2000
    Date of Event
    May 17, 2000
    Report Date
    September 26, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT FOLLOWING A QUALITY CONTROL PROCEDURE, THE COLLIMATOR STORAGE RACK MISSED THE FINAL POSITION, BY ABOUT 1 DEGREE. THIS CAUSED A COLLISION BETWEEN HEAD #2 AND THE COLIMATOR. THERE WAS NO INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2155-3002B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *