BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM PCC-EDO 2.5W

    MDR report key: 248885 · Received November 8, 1999

    Report

    Report Number
    MW1017495
    Event Type
    Malfunction
    Date Received
    November 8, 1999
    Date of Event
    October 27, 1999
    Report Date
    November 3, 1999
    Manufacturer
    HGM, INC.
    Product Code
    GFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT HAD BEEN AWAITING INSTALLATION BY HGM, SINCE EARLY SEPTEMBER 1999. THE CO WAS UNABLE TO COMPLETE THE INSTALL, "DUE TO PERSONNEL PROBLEMS". AFTER REPEATED REQUESTS WERE MADE A REP WAS DISPATCHED AND HE ATTEMPTED TO OPERATE THE LASER. THE UNIT'S CIRCUIT BREAKER TRIPPED AND WOULD NOT RESET. WHEN THE CASE WAS OPENED, NO OBVIOUS FAULT WAS SEEN SO POWER WAS RETURNED AND AN ARC WAS SEEN TO RISE FROM THE POWER SUPPLY, ACCOMPANIED BY A LOUD POP. A WIRE WAS FOUND TO HAVE INSULATION DAMAGE DUE TO CONTACT WITH A METAL CASE. THIS WAS REPAIRED, BUT THE SYSTEM STILL WOULD NOT WORK. THE HGM REP SAID THE PROBLEM WAS DUE TO SOME "LEAKY" CAPACITORS THAT "SHOULD NEVER HAVE BEEN IN THE PRODUCTION AREA, AS THEY WERE KNOWN TO BE BAD..." REPORTER IS STILL WAITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM PCC-EDO 2.5W LASER GFX HGM, INC. PC-EDO 2.5W NON-SMART *

    Patients

    Seq Age Sex Outcome Treatment
    1 *