BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 1639460 · Received March 17, 2010

    Report

    Report Number
    2916710-2010-00022
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K042720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN EXPLAINED TO THE CUSTOMER THAT, BECAUSE THE TWO PLANS WERE IN THE SAME COURSE, IT IS POSSIBLE THAT OBI RETAINED THE VALUES OF THE FIRST SITE. THE USER WAS ADVISED THAT THEY CAN PUT THE TWO PLANS IN TWO DIFFERENT COURSES, OR IF THEY CHOOSE TO USE THE SAME COURSE, THEY SHOULD CLOSE OUT OF THE PT OR OBI AFTER EACH PLAN THAT IS TREATED. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A MALFUNCTION IN THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, 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 CUSTOMER REPORTED THAT DURING THE PT'S SPINE AND HIP IMAGING, THE THERAPISTS VERIFIED THE SHIFTS VALUES DISPLAYED ON THE OBI WORKSTATION DID NOT MATCH WHAT WAS NEEDED ON THE OBI SCREEN. THE KV/KV IMAGES WERE INITIALLY PERFORMED ON THE SPINE AND WERE ABLE TO MATCH, APPLY SHIFT, AND TREAT. HOWEVER, WHEN THE HIP WAS IMAGED AND ATTEMPTED TO MATCH, THE OBI DISPLAYED INCORRECT SHIFT VALUES. ESSENTIALLY, THE SHIFTS VALUES HAD MOVED THE COUCH BACK TO THE SPINE LOCATION. THERE WAS NO INJURY TO PT. THE THERAPISTS NOTICED THE SHIFTS PRIOR TO TREATMENT, AND NO PT DATA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-BOARD IMAGER (OBI) MEDICAL PARTICAL CHARGED RAD. THERAPY IYE VARIAN MEDICAL SYSTEMS H08

    Patients

    Seq Age Sex Outcome Treatment
    1