BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRASYS

    MDR report key: 5802677 · Received July 19, 2016

    Report

    Report Number
    5802677
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    May 13, 2016
    Report Date
    June 10, 2016
    Manufacturer
    SEBIA INC
    Product Code
    JJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAST MONTH WE HAD AN ELECTRICAL SAFETY CONCERN WITH THE SEBIA HYDRASYS UNIT. THE INSTRUMENT WAS TURNED ON TO PERFORM AN ELECTROPHORESIS RUN. THE TECHNOLOGIST WHO WAS OPERATING THE INSTRUMENT HEARD A LOUD POPPING NOISE AND SMELLED ELECTRICAL FIRE. WE UNPLUGGED THE UNIT AND NOTIFIED THE FIRE DEPARTMENT TO MAKE SURE THERE WAS NO FIRE IN THE WALL ELECTRICAL OUTLET. THE SEBIA COMPANY WAS NOTIFIED. WE HAD THE SAME PROBLEM IN THE FALL OF LAST YEAR AT THE SAME LOCATION, AND WITH THE SAME HYDRASYS INSTRUMENT. A SIMILAR OCCURRENCE ALSO TOOK PLACE TWO YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457667 HYDRASYS APPARATUS, ELECTROPHORESIS JJN SEBIA INC

    Patients

    Seq Age Sex Outcome Treatment
    1