BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKYLIGHT

    MDR report key: 481486 · Received August 27, 2003

    Report

    Report Number
    2916556-2003-00012
    Event Type
    Other
    Date Received
    August 27, 2003
    Date of Event
    July 31, 2003
    Report Date
    August 25, 2003
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AUTOMATIC COLLIMATOR EXCHANGE, 2 TECHNICIANS INTERVENED AND A COLLIMATOR FELL OFF THE GATE ONTO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLIGHT NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2160-3000A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA