BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOMATOM EMOTION 16

    MDR report key: 1074019 · Received July 9, 2008

    Report

    Report Number
    2240869-2008-00007
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 9, 2008
    Manufacturer
    SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K050297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BALANCE BLOCK IS SECURED TO THE GANTRY DISC BY 3 BOLTS AND NUTS, THE ASSEMBLY PROCESS IS CLEARLY DEFINED IN THE MANUFACTURING INSTRUCTION. DUE TO A MISTAKE MADE DURING PRODUCTION, THE NUTS USED TO SECURE THE WEIGHT WERE NOT TIGHTEN TO THE RECOMMENDED SPECS CAUSING THE BALANCE BLOCK TO LOOSEN AND DETACH FROM THE GANTRY. ACCORDING TO THE INVESTIGATION PERFORMED BY OUR INTN'L AFFILIATE, WE HAVE NO OTHER REPORTED EVENT, WE REPORT THIS AS A SINGLE CASE. NOTE: THERE WAS NO REPORTED INJURY DURING THIS EVENT. WE WERE UNABLE TO DESELECT "FEMALE" IN PT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE DURING DAILY CALIBRATION BEFORE PT SCANS, ONE OF THE BALANCE BLOCKS AFIXED TO THE ROTATING GANTRY DISC, DETACHED FROM THE GANTRY THROUGH THE GAP BETWEEN FRONT AND REAR COVERS. THE BALANCE BLOCK HIT THE EXTENSION OF PT CABLE AND FELL TO FLOOR. SINCE THIS EVENT OCCURRED DURING THE DAILY CALIBRATION, NO PT EXAMINATION WERE BEING CONDUCTED, AND NO INJURIES WERE REPORTED. DAMAGE TO THE SCANNER WAS PRIMARILY LIMITED TO INTERNAL COMPONENTS WITH SOME COSMETIC DAMAGE TO THE PT TABLE AND THE GANTRY COVERS. ALL DAMAGED PARTS WERE REPLACED, AND THE GANTRY WAS REBALANCED BY LOCAL SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOMATOM EMOTION 16 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD. 10165977 NA

    Patients

    Seq Age Sex Outcome Treatment
    1