BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM

    MDR report key: 10861 · Received January 6, 1994

    Report

    Report Number
    MW1000321
    Event Type
    Malfunction
    Date Received
    January 6, 1994
    Date of Event
    December 6, 1993
    Report Date
    December 17, 1993
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT WAS PERFORMING REQUIRED FUNCTIONS PROPERLY BUT THE ISOLATED POWER SYSTEM INTERMITTENTLY WENT INTO ALARM. OUR INVESTIGATION REVEALED THE 1200 WATT HEATING ELEMENT WAS DEFECTIVE AND CURRENT LEAKAGE WAS IN EXCESS OF 2000 MICRO AMPS (MAXIMUM MEASUREMENT CAPABILITY OF OUR TEST ANALYZER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOTHERM DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 400 M

    Patients

    Seq Age Sex Outcome Treatment
    1 *