BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS POLYDORIS

    MDR report key: 2030940 · Received March 24, 2011

    Report

    Report Number
    MW5019937
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 24, 2011
    Manufacturer
    SIEMENS
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED AN ORDER FOR 14 X-RAYS TO BE DONE. PT ACTUALLY RECEIVED 17 WITH SOME OF THESE VIEWS OVERLAPPING. IF YOU TAKE THIS INTO ACCOUNT, THEN IT MAY PLAY INTO THE FACT THAT I WAS BURNED BY THE MACHINE. I RECEIVED BURNS OVER MY LEFT KIDNEY. THE BURNS LOOKED LIKE A SEMI CIRCULAR PATCH 5 1/2 - 6 IN. IN DIAMETER. IT FELT LIKE SUNBURN. THE AREA WAS RED AND INFLAMED. THIS RESOLVED AFTER ABOUT 4 DAYS. I NOTICED THESE BURNS WHILE DRYING OFF WITH A TOWEL. I COULD FEEL THE DISCOMFORT WHEN THE TOWEL SCRAPED AGAINST IT. IT DIDN'T MAKE THE CONNECTION IMMEDIATELY BETWEEN THE X-RAYS AND THE BURN. I REMEMBERED THAT THEY HAD TO DO A RETAKE ON THE X-RAY AND I RECEIVED 2 IN THE EXACT SAME SPOT. THE BURN MATCHED THE SPOT WHERE THEY DID THE RETAKE. THEY NEEDED TO SEE THROUGH THE FECAL MATTER IN THE GI TRACT SO THEY MAY HAVE INCREASED THE OUTPUT ON THE MACHINE IN ORDER TO DO SO. AFTER RECEIVING THE BURN I FELT WEIRD, COULDN'T SLEEP, EXPERIENCED NAUSEA, HALOS, COULDN'T EAT AND FOUND MYSELF PACING. I WAS DESPERATELY TRYING TO FIGURE OUT WHAT WAS GOING ON. I WENT BACK TO (B)(6), WHERE I HAD THE X-RAYS DONE, AND SPOKE WITH THE RADIOLOGIST. HE DENIED THAT IT WAS POSSIBLE TO GET BURNED FROM THE UNIT AND BASICALLY CALLED ME A LIAR. I HAVE DONE RESEARCH AND HAVE SEEN RECALLS IN UNITS LIKE THIS ONE FOR SIMILAR REASONS. THESE DEVICES NEED TO BE CALIBRATED ONCE A YR AND THE PAPERWORK FOR THAT IS INSPECTED SO EVERY 2 YRS. DOES ANYONE EVER INSPECT THE PROCESS TO CALIBRATE THE MACHINE? IS THERE A COMPUTER SYSTEM THAT LOGS CALIBRATION? AND ACCOUNTABILITY FOR THE SESSION? THE TEST READING ON THEIR LAST STATE INSPECTION WAS DONE (B)(6) 2010. THEY TEST ON THE LUMBAR SACRAL SHOT, THEY TESTED AT 266 MR, ACCORDING TO THE PAPERWORK. THEY DON'T DO ANY HANDS ON TESTING, SO IT'S ALL HEARSAY. THIS INFO WAS PROVIDED BY THE STATE INSPECTION. I WOULD LIKE TO KNOW WHAT GUIDELINES FOR INSPECTION ARE? THE STATE INSPECTOR SAYS THAT I NEED TO SEND IN A FORMAL LETTER TO GET A RESPONSE. I CANNOT BELIEVE THAT THERE IS NO CHECK AND BALANCE SYSTEM FOR THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS POLYDORIS XRAY JAA SIEMENS
    2 SIEMENS XRAY JAA SIEMENS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other