BEUDAMED
    FDA Adverse Event Summary report: N

    GEMINI TF PET/CT 16 SLICE

    MDR report key: 1942610 · Received December 20, 2010

    Report

    Report Number
    1525965-2010-00046
    Date Received
    December 20, 2010
    Report Date
    October 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K052640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: (B)(4). INITIAL MDR MAILED ON (B)(6), 2010.

    Description of Event or Problem · 1

    AN INTERNALLY SUBMITTED COMPLAINT REPORTED THAT ON THE REAR DOORS FOR THE COMMON IMAGE RECONSTRUCTION SYSTEM (CIRS) AND COMBINED RACK CONSOLE (CRC) CABINETS, THERE IS NO SEPARATE GROUND WIRE GOING FROM GROUND TO THE DOOR. THE DOORS WERE ELECTRICALLY FLOATING (NOT GROUNDED); THEREFORE, IF THE DOOR WAS ENERGIZED BY A PINCHED OR DAMAGED POWER CABLE, THERE WOULD BE NO PATH TO GROUND. THE DOOR COULD THEN POSSIBLY BECOME "HOT" CAUSING A POTENTIAL SHOCK HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI TF PET/CT 16 SLICE KPS, JAK KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 453567983931

    Patients

    Seq Age Sex Outcome Treatment
    1