BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 1586895 · Received January 14, 2010

    Report

    Report Number
    2916710-2009-00079
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 22, 2009
    Report Date
    December 22, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    LHN
    PMA / PMN Number
    K042720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN MULTIPLE REPORTS OF THIS MALFUNCTION, NO SERIOUS INJURY HAS RESULTED, AND NO MEDICAL INTERVENTION BEYOND EXAM AND/OR DIAGNOSTIC TESTING HAS RESULTED. VARIAN SERVICE IS ON SCHEDULE TO PERFORM A SITE VISIT TO APPLY A MODIFICATION TO THE DEVICE. THIS MODIFICATION IS A VARIAN APPROVED MODIFICATION WHICH REPLACES THE ORIGINALLY DESIGNED VELCRO FASTENERS WITH RETAINING SCREWS. VARIAN HAS COME TO A DECISION TO REPORT INCIDENTS INVOLVING MEDICAL INTERVENTION (X-RAY AND CT SCANS) OR OBSERVATIONS. IN A PREVIOUS REPORT OF THIS MALFUNCTION, A PT WAS REFERRED FOR CT EXAM (WHICH WAS NEGATIVE). NO ADDITIONAL F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED ONCOLOGY TREATMENT, THE COVER OF THE OBI DETECTOR FELL OFF THE MACHINE DURING GANTRY ROTATION. ALTHOUGH, THE COVER DETACHED DURING TREATMENT AND STRUCK THE PT IN THE HEAD, NO INJURY OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1