BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGUS NUCLEAR CAMERA

    MDR report key: 439342 · Received January 20, 2003

    Report

    Report Number
    MW1027319
    Event Type
    Malfunction
    Date Received
    January 20, 2003
    Date of Event
    January 9, 2003
    Report Date
    January 20, 2003
    Manufacturer
    ADAC/JD TECHNICAL SERVICES, INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBLEM BEGAN IN 2002 WHEN A NUCLEAR CAMERA ALMOST HIT A PT'S HEAD WHILE RETURNING TO "HOME" POSITION. THE PROBLEM REPEATED ITSELF IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGUS NUCLEAR CAMERA NUCLEAR CAMERA KPS ADAC/JD TECHNICAL SERVICES, INC. ARGUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR