BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA CAMERA SYSTEM

    MDR report key: 12518607 · Received September 23, 2021

    Report

    Report Number
    12518607
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    June 23, 2021
    Report Date
    September 13, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POOR IMAGE QUALITY WAS DEMONSTRATED ON ONE OF TWO CAMERA HEADS ON THE NUCLEAR MEDICINE AXIS GAMMA CAMERA. THE CAMERA WAS LIMITED TO PERFORMING TWO EXAM TYPES, UNABLE TO PERFORM THE FULL GAMUT OF EXAMS. THE MOTHERBOARD/FULL ELECTRONIC ASSEMBLY OF HEAD 2 WAS REPLACED, AND THE CAMERA WAS FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415990 GAMMA CAMERA SYSTEM SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.

    Patients

    Seq Age Sex Outcome Treatment
    1