BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC

    MDR report key: 1911338 · Received November 24, 2010

    Report

    Report Number
    2916710-2010-00130
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS EVENT, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE VARIAN FIELD SERVICE ENGINEER WAS TROUBLESHOOTING THE CLINAC AND HE RECEIVED AN ELECTRICAL SHOCK BETWEEN THE LEFT HAND AND THE RIGHT HAND AT THE MOMENT HE WAS RECONNECTING THE CABLE COMING FROM THE 6 DIODES CR13-18 TO THE PFN. THE FE WAS LOOKING FOR THE CAUSE OF THE FAULT "MOD". HE SWITCHED OFF THE MODULATOR BY OPENING THE MAIN CIRCUIT BREAKER. HE DISCHARGED DIFFERENT COMPONENTS USING THE GROUND STICK. HE DISCONNECTED THE CABLE COMING FROM THE 6 DIODES CR13-18 TO THE PFN. THE GROUND STICK WAS STILL APPLIED ON THE JUNCTION FROM THE ONE THE CABLE WAS DISCONNECTED. HE SWITCHED ON THE MODULATOR (HV). AFTER SOME QUICK OBSERVATION, HE TURNED OFF THE HV, AND THEN SWITCHED OFF THE MAIN CIRCUIT BREAKER. HE WENT TO THE MODULATOR, AND HE TOOK THE CABLE WITH THE LEFT HAND TO RECONNECT IT. WHEN THE LUG AT THE END OF THE CABLE WAS PRETTY CLOSE TO THE JUNCTION, THERE HAS BEEN A FLASH. THE ASSUMPTION IS THAT THE CAPACITORS C1 C2 WERE NOT TOTALLY DISCHARGED. IT HAS BEEN ABOUT 1 MIN BETWEEN THE HV WAS TURNED OFF AND THE MOMENT THERE WAS THE FLASH. THE FIELD ENGINEER HAD NOT APPLIED THE GROUND STICK AT THE END OF THE CABLE OR AT ANY POINT BETWEEN T1 AND THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS H27

    Patients

    Seq Age Sex Outcome Treatment
    1