BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS

    MDR report key: 373872 · Received January 23, 2002

    Report

    Report Number
    2916556-2002-00004
    Event Type
    Malfunction
    Date Received
    January 23, 2002
    Date of Event
    November 26, 2001
    Report Date
    January 23, 2002
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Removal / Correction Number
    010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT THE INSERT FOR THE PIN HOLE COLLIMATOR DETACHED FROM ITS HOLDER. THERE WERE NO INJURIES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGUS NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2145-3007A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *