BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 2043586 · Received March 29, 2011

    Report

    Report Number
    2916710-2011-00027
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    VARIAN MEDICAL
    Product Code
    IYE
    PMA / PMN Number
    K042720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. METHOD: THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER STATES THE THERAPISTS HAVE INTERMITTENTLY NOTED, THAT WHEN THEY ARE PROMPTED TO CENTER THE COUCH PRIOR TO TAKING A CBCT AND AFTER THE CBCT IS COMPLETED, THEY GET INCORRECT VALUES DISPLAYED FOR MOVING THE COUCH BACK TO ORIGINAL POSITION PRIOR TO PERFORMING AN IMAGE MATCH. THE CUSTOMER STATES THAT THIS HAS BEEN REPORTED TO THEIR SERVICE REP AND HE HAS ATTEMPTED TO INVESTIGATE BUT HAS BEEN UNABLE TO REPRODUCE THE ISSUE. THE ISSUE OCCURRED AGAIN TODAY: THE RT STAFF REPORT THEY WERE SET UP AT COUCH VERTICAL=19.4, LONG=32.5, LAT-96.5. THEY WERE PROMPTED TO CENTER THE COUCH BY THE SYSTEM AND THE LAT WAS AT 0.0 WHEN THE CBCT WAS TAKEN (OTHER VALUES REMAINED THE SAME). AFTER THE CBCT WAS COMPLETED, THE STAFF REPORTED THEY WERE PROMPTED TO MOVE THE COUCH TO VERTICAL=38.6, (THEY DID NOT RECORD THE LONG VALUE), AND LAT=0.3. THE CUSTOMER STATES THAT THE STAFF NOTED THIS WAS AN INCORRECT VALUE AND DID NOT MOVE THE COUCH TO THIS POSITION. THIS PATIENT HAS BEEN SUCCESSFULLY CBCTED ON OTHER DATES. THE CUSTOMER STATES THAT THIS ISSUE DOES NOT APPEAR TO BE PATIENT SPECIFIC. THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-BOARD IMAGER (OBI) ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL H07

    Patients

    Seq Age Sex Outcome Treatment
    1