BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE

    MDR report key: 285453 · Received July 12, 2000

    Report

    Report Number
    2916556-2000-00300
    Event Type
    Malfunction
    Date Received
    July 12, 2000
    Date of Event
    April 20, 2000
    Report Date
    June 28, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER INITIATED A COLLIMATOR EXCHANGE AND LEFT THE ROOM. WHEN THE CUSTOMER RETURNED, THE COLLIMATOR EXCHANGE HAD NOT TAKEN PLACE, THE CAMERA WAS BEEPING AND THERE WERE NO ERROR MESSAGES. THE CUSTOMER INSERTED THE TRAY BACK INTO THE EXCHANGER AND THEN PULLED IT BACK OUT. AT THIS TIME THE MEGP COLLIMATOR, WHICH WAS UNLATCHED FROM THE DETECTOR AND HELD ONLY BY FRICTION FROM THE CORNER BLOCK PINS, FELL AND HIT THE EXTENDED TRAY CAUSING ONE CORNER TO "BOUNCE UP", IMPACTING THE EXPOSED CRYSTAL OF DETECTOR 1. THE COLLIMATOR CONTINUED ITS FALL, COMING TO REST ON DETECTOR 2. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2155-3000B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN