BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTE

    MDR report key: 354927 · Received October 3, 2001

    Report

    Report Number
    2916556-2001-00027
    Event Type
    Other
    Date Received
    October 3, 2001
    Date of Event
    September 3, 2001
    Report Date
    September 26, 2001
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COLLIMATOR COLLISION SENSITIVITY WAS NOTED BY THE COMPANY'S REP TO BE GREATER THAN EXPECTED BY THE USER AND COULD RESULT IN EXCESS PRESSURE BEING APPLIED TO A PT IN THE EVENT OF A COLLISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44619 FORTE NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2155-3002B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *