BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS EPIC

    MDR report key: 606366 · Received May 18, 2005

    Report

    Report Number
    2916556-2005-00391
    Event Type
    Malfunction
    Date Received
    May 18, 2005
    Date of Event
    March 1, 2005
    Report Date
    May 18, 2005
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYY
    Removal / Correction Number
    2916556-07/08/05-025C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARGUS FORK THAT HOLDS THE DETECTOR LOOKS LIKE IT HAS FRACTURE. FRACTURE IS LOCATED AT THE END OF THE MAIN ARM BEFORE THE FORKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA