BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI TF 16

    MDR report key: 1854043 · Received September 2, 2010

    Report

    Report Number
    1525965-2010-00026
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND)
    Product Code
    KPS
    PMA / PMN Number
    K052640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS COMPLAINT IS NOT COMPLETE AT THIS POINT. THE DATA FROM THE CUSTOMER SITE IS BEING ANALYZED TO IDENTIFY THE ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER SITE ALLEGING DEFICIENCIES IN THE IMAGE QUALITY OBTAINED WITH THE USE OF PULMONARY GATING ON A GEMINI TF 16 SLICE SYSTEM. THERE HAS BEEN NO REPORTS OF ANY MISDIAGNOSIS, BUT THE IMAGES HAVE BEEN DEEMED UNACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI TF 16 PET/CT SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1