BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-THERM

    MDR report key: 35846 · Received August 21, 1996

    Report

    Report Number
    MW1009778
    Event Type
    Malfunction
    Date Received
    August 21, 1996
    Date of Event
    July 15, 1996
    Report Date
    August 21, 1996
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SPILLAGE OR CONDENSATION DRIPPED ONTO MAIN POWER FEED LUG ON BACK OF MAIN POWER SWITCH. THIS EITHER DIRECTLY STARTED OVERHEAT3ING THAT CONNECTION OR OVER TIME CORRODED CASUING IMPEDENCE OF CONNECTION TO INCREASE AND THEREBY CAUSING OVERHEATING OF CONNECTION. CO NOW SENDS SPLASH COVER WITH SWITCH, BUT MAY NOT HELP IF THERE IS INTERNAL CONDENSATION. THIS IS SECOND POWER SWITCH REPLACED WITH THIS FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-THERM HYPOTHERMIA BLANKET DWJ GAYMAR INDUSTRIES, INC. MTA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *