BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT LASER

    MDR report key: 24737 · Received August 21, 1995

    Report

    Report Number
    MW1006742
    Event Type
    Malfunction
    Date Received
    August 21, 1995
    Date of Event
    July 20, 1995
    Report Date
    August 9, 1995
    Manufacturer
    HGM MEDICAL LASER SYSTEMS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CIRCUIT BREAKER WAS TRIPPING WHEN POWER WAS INCREASED TO 1 WATT. INSTALLATION INSTRUCTIONS REQUIRE 20 AMP CIRCUIT. EQUIPMENT WAS USED ON 20 AMP CIRCUIT, HOWEVER BREAKERS TRIPPED. UPON TESTING BY IN-HOUSE BIOMEDICAL ENGINEERING DEPT, IT WAS FOUND THAT THE 20 AMP CIRCUIT WAS INADEQUATE. CO THEN INSTRUCTED RPTR TO INSTALL A 20 AMP LONG DELAY STYLE CIRCUIT BREAKER. PARTS ARE ORDERED AND WILL BE INSTALLED AS SOON AS THEY ARRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT LASER COMPACT LASER GEX HGM MEDICAL LASER SYSTEMS, INC. 110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA