BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGLE BIOMEDICAL SCIENCES

    MDR report key: 10983 · Received December 23, 1993

    Report

    Report Number
    10983
    Event Type
    Malfunction
    Date Received
    December 23, 1993
    Date of Event
    December 15, 1993
    Report Date
    December 20, 1993
    Manufacturer
    TRIANGLE BIOMEDICAL SCIENCES
    Product Code
    IDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS NOT BEING USED AND THE FLOTATION DISH HAD BEEN REMOVED FROM THE HEATING WELL. THE HEATING UNIT HAD BEEN ACCIDENTALLY TURNED ON AND THE PLASTIC FRAME OF THE DEVICE WAS STARTING TO MELT AND SMOKE WHILE IT WAS POSITIONED ON A LAB COUNTER. FORTUNATELY, A LAB TECH WORKING IN THE AREA SMELLED THE BURNING PLASTIC AND INVESTIGATED. THE DEVICE WAS UNPLUGGED AND TRANSPORTED TO OUR BIOMED DEPT FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGLE BIOMEDICAL SCIENCES HISTOLOGY FLOATATION WORK STATION IDY TRIANGLE BIOMEDICAL SCIENCES H-FWS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other