BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA GAMMAKNIFE, AB

    MDR report key: 1589590 · Received January 26, 2010

    Report

    Report Number
    MW5014534
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ELEKTA, AB
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EMERGENCY STOP WAS ACTIVATED (DEPRESSED) WHILE GAMMAKNIFE UNIT WAS IN TREATMENT POSITON, DURING A MONTHLY QA PROCEDURE. WHEN EMERGENCY STOP BUTTON WAS PULLED OUT AND RESET BUTTON DEPRESSED, GAMMAKNIFE FAILED TO MOVE TREATMENT COUCH OUT AND CLOSE THE TREATMENT DOOR. NO PT WAS INVOLVED. CAUSE: RELAY ASSOCIATED WITH THE EMERGENCY STOP FAILED TO DISENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEKTA GAMMAKNIFE, AB GAMMAKNIFE IWB ELEKTA, AB C

    Patients

    Seq Age Sex Outcome Treatment
    1