BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM

    MDR report key: 278607 · Received May 17, 2000

    Report

    Report Number
    MW1018937
    Event Type
    Malfunction
    Date Received
    May 17, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 17, 2000
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PERFUSIONIST REPORTED TO BIOMEDICAL DEPT THAT THIS UNIT FAILS TO FUNCTION PROPERLY DURING HEART BY-PASS SURGERY CASE. UNIT WOULD QUIT OPERATING AND GO INTO PRIMING SEQUENCE. THIS OCCURRED SEVERAL TIMES DURING THE CASE. UNIT WAS REPLACED WITH BACK-UP AND BROUGHT TO BIOMED SHOP FOR INSPECTION. COULD NOT DUPLICATE PROBLEM DURING TESTING BUT FOUND L1 & L2 LEADS SEVERELY SCORCHED/MELTED AT 15W POWER SWITCH/CIRCUIT BREAKER, ALSO FOUND NAME PLATE RATING ON THIS UNIT WAS INCORRECT, QUESTIONABLY 12 AMP AT 240 VOLT, 50 HZ; SHOULD BE 16 AMP AT 115 VOLT, 60 HZ. ALSO FOUND THAT OPERATIONAL AND TECHNICAL MANUAL FOR THIS UNIT LISTS THE 115 VOLT CURRENT RATING AT 15.5 AMP IN THE EQUIPMENT SPECS BUT SHOWS THE POWER SWITCH CIRCUIT RATED AT ONLY 10 AMPS ON THE 115 VOLT ELECTRICAL SCHEMATIC. THE ACTUAL CURRENT RATING OF THE CIRCUIT BREAKER IN THE UNIT IS 20 AMPS. WITH CONFLICTING RATINGS, SAFE LOAD DISTRIBUTION COULD BE MISCALCULATED AND CAUSE SIGNIFICANT PROBLEMS WITH CIRCUIT BREAKER TRIPPING AT THE POWER DISTRIBUTION PANEL DURING THE CASES. EXACT SAME PROBLEM OCCURRED WITH ANOTHER LIKE MODEL UNIT - CINCINNATI SUB-ZERO MODEL 400MR IN NOVEMBER, 2000. L1 & L2 LEADS WERE FOUND SEVERELY MELTED. 15W CIRCUIT BREAKER POWER SWITCH WOULD NOT TRIP INSTANTLY ONLY OCCASIONALLY OVER A PERIOD OF TIME. NAMEPLATE RATING ON THIS UNIT WAS CORRECT. SWITCH AND LEADS WERE REPLACED. AN OLDER CINCINNATI, SUB-ZERO MODEL 400M HAS BEEN IN SVC IN FACILITY SINCE 8/93 BUT HAS NEVER HAD THIS MALFUNCTION. ALTHOUGH THE NAMEPLATE IS CORRECT THE SAME MISTAKE ON THE ELECTRICAL SCHEMATIC APPEARS IN THE OPERATION AND TECHNICAL MANUAL FOR THE MODEL 400M AS THE MANUAL FOR THE 400MR. MFR PROVIDED REPLACEMENT SWITCH/CIRCUIT BREAKER AND CORRECT NAMEPLATE RATING LABEL FOR THIS UNIT AT NO CHARGE ON 5/4/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOTHERM HYPO/HYPERTHEMIA UNIT DWJ CINCINNATI SUB-ZERO PRODUCTS INC. 400MR NA
    2 HEMOTHERM HYPO/HYPERTHEMIA UNIT DWJ CINCINNATI SUB-ZERO PRODUCTS INC. 400MR NA
    3 HEMOTHERM HYPO/HYPERTHEMIA UNIT DWJ CINCINNATI SUB-ZERO PRODUCTS INC. 400M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *