BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOD FLOW METER

    MDR report key: 51967 · Received November 15, 1996

    Report

    Report Number
    MW4001715
    Event Type
    Malfunction
    Date Received
    November 15, 1996
    Date of Event
    August 23, 1996
    Report Date
    November 10, 1996
    Manufacturer
    TRANSONIC SYSTEMS, INC.
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD USING CAUTERY. FLOW UNIT STARTED TO EMIT SMOKE, SPARKS AND FUMES. UNIT REMOVED. FAILURE APPARENTLY CAUSED BY A "SHORT" IN A CERAMIC CAPACITOR. FLOW METER WAS LEFT PLUGGED IN WHILE CAUTERY IN USE. MFR INSTRUCTIONS STATE TO TURN OFF FLOW METER WHEN NOT IN USE TO PREVENT PROBLEMS OF THIS SORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOD FLOW METER BLOOD FLOW UNIT DPW TRANSONIC SYSTEMS, INC. TRANSONIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other