BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTE

    MDR report key: 295147 · Received September 8, 2000

    Report

    Report Number
    2916556-2000-00336
    Event Type
    Other
    Date Received
    September 8, 2000
    Date of Event
    August 23, 2000
    Report Date
    September 8, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT FORTE SCANNER WAS SET UP TO PERFORM A CARDIAC-90 SCAN. ONCE THE SCAN WAS STARTED, THE EXAM TABLE MOVED UP AND THE PT WAS PRESSED INTO THE DETECTOR. PROCEDURE WAS STOPPED, AND RESTARTED USING THE SAME EQUIPMENT ONCE THE PT WAS READY TO CONTINUE. PT'S CHEST WAS ALLEGEDLY BRUISED, BUT SERIOUS INJURY DID NOT OCCUR, AND MEDICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2155-3001B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *