BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMOKE EVACUATOR

    MDR report key: 37141 · Received July 3, 1996

    Report

    Report Number
    37141
    Event Type
    Other
    Date Received
    July 3, 1996
    Date of Event
    March 5, 1996
    Report Date
    March 11, 1996
    Manufacturer
    IC MEDICAL, INC.
    Product Code
    FYD
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMOKE EVACUATOR WAS BEING USED FOR A BREAST REDUCTION FOR APPROX ONE HR. RPTR SAW SMOKE AND RED SPARKS COMING OUT OF THE FRONT OF THE MACHINE. A HOLE QUICKLY BURNED THROUGH THE MACHINE. MACHINE WAS TURNED OFF AND REMOVED FROM THE OR. BIO-MED REPORT: THIS UNIT IS A DEMO. THE FRONT PANEL MELTED NEAR THE FILTER CONNECTOR. IT HAS A RIBBON CABLE SUPPLYING POWER TO A FRONT PANEL WARNING "SINGLE USE FILTERS." "FLOW" SET AT MAX; "TIME" SET AT 1/4 CW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOKE EVACUATOR SMOKE EVACUATION SYSTEM FYD IC MEDICAL, INC. 350 D *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other