BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBETRON

    MDR report key: 1064440 · Received June 23, 2008

    Report

    Report Number
    2953704-2008-00001
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 20, 2008
    Manufacturer
    INTRAOP MEDICAL CORP.
    Product Code
    LHN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTABLE INCIDENT THAT OCCURRED IN 2008 AT CUSTOMER SITE AND WAS REPORTED TO US BY OUR DISTRIBUTOR. THIS INVOLVED THE MOBETRON MODEL 1000 ELECTRON LINEAR ACCELERATOR THAT WAS SET UP DURING TESTING AND HAD A FAILURE OF A DOCKING DRIVE SCREW AND NUT ASSEMBLY, RESULTING IN A TREATMENT HEAD DROPPING A SHORT DISTANCE. FORTUNATELY, NO INJURIES WERE INVOLVED. INTRAOP MEDICAL CORP. IS CONSIDERING THIS INCIDENT A "MALFUNCTION", SINCE A REOCCURRENCE DURING AN ACTUAL TREATMENT COULD LIKELY RESULT IN A DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT EXPERIENCE. THE REMEDIAL ACTION INVOLVES EITHER A SELF INSPECTION BY OUR CUSTOMERS TO ENSURE THE NUT HAS NOT FAILED, AS EVIDENCED BY BRASS DEBRIS/FILINGS VISIBLE AROUND THE NUT, DOCKING DRIVE SCREW AND THEIR COVER, OR AN IMMEDIATE INSPECTION BY INTRAOP SERVICE PERSONNEL. OUR CUSTOMERS HAVE BEEN VERBALLY NOTIFIED AND AN ADVISORY NOTICE HAS BEEN SENT ALERTING THEM OF THIS POTENTIAL PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBETRON MOBILE ELECTRON LINEAR ACCELERATOR LHN INTRAOP MEDICAL CORP. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1