BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFCII

    MDR report key: 43064 · Received September 10, 1996

    Report

    Report Number
    1017522-1996-00008
    Event Type
    Malfunction
    Date Received
    September 10, 1996
    Date of Event
    August 5, 1996
    Report Date
    September 5, 1996
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STOP PIN IN THE DOWN ARM BROKE THUS ALLOWING THE WIRES TO TWIST INSIDE THE ARM LEADING TO A SHORT TO GROUND. THIS "SHORT" THEN CAUSES THE TRANSFORMER TO OVERHEAT AND THEN BEGIN TO SMOKE. THE DR THEN CALLED THE FIRE DEPT WHO THEN EXTINGUISHED THE SMOKING TRANSFORMER. UNIT IS 13 YRS OLD. THE SHORT MENTIONED ABOVE IS ON THE OUTPUT OR SECONDARY LOW VOLTAGE SIDE OF TEH TRANSFORMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFCII LIGHT FANTASTIC II EAZ PELTON & CRANE HBC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *