BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 284769 · Received June 30, 2000

    Report

    Report Number
    1720381-2000-00003
    Event Type
    Malfunction
    Date Received
    June 30, 2000
    Date of Event
    June 1, 2000
    Report Date
    June 30, 2000
    Manufacturer
    FISMA
    Product Code
    IQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    HGM SVC ENGINEER WAS INSTALLING A NEW MONOSHUTTER WITH K3 LASER AND OBSERVED THAT THE LASER FIRED WITHOUT CLOSING THE SHUTTER ON THE MONOSHUTTER. NO PTS OR HOSP PRESONNEL WERE INVOLVED, BECAUSE THE PROBLEM WAS FOUND DURING INSTALLION. THE SVC ENGINEER REMOVED MONOSHUTTER FROM THE SYSTEM, PACKAGED UNIT AND RETURNED IT TO THE FACTORY FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM MONOSHUTTER IQJ FISMA K45-A-K03-1-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other