BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 18562 · Received December 28, 1994

    Report

    Report Number
    MW1004588
    Event Type
    Malfunction
    Date Received
    December 28, 1994
    Date of Event
    December 16, 1994
    Report Date
    December 27, 1994
    Manufacturer
    MITSUBISHI INTL. CORP.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE A THERAPIST WAS UNDER THE TABLE VERIFYING THE SOURCE-TO-SKIN DISTANCE, THE TREATMENT TABLE MOTORED DOWN AND CRASHED INTO THE BLOCK TRAY HOLDER. THE EMERGENCY STOP BUTTON WAS PUSHED AND THE TABLE STOPPED. THE PT AND THERAPIST WERE NOT INJURED. THE HOSP HAS HAD THE ACCELERATOR FOR FIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATOR IYE MITSUBISHI INTL. CORP. EXL-14

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR