BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCINNATI SUB ZERO

    MDR report key: 20109 · Received January 7, 1995

    Report

    Report Number
    20109
    Event Type
    Injury
    Date Received
    January 7, 1995
    Date of Event
    November 8, 1994
    Report Date
    January 6, 1995
    Manufacturer
    CINCINNATI SUB ZERO PRODUCTS
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IN THE AUTOMATIC MODE WITH A RECTAL PROBE TO MONITOR THE TEMPERATURE. THE HYPO-HYPERTHERMIA UNIT FAILED TO PROPERLY MONITOR THE WATER TEMPERATURE AND CAUSED RAISED REDDENED AREAS IN THE PATTERN OF THE BLANKET ON THE BODY OF THE PT. THE UNIT WAS PULLED FROM SERVICE PER HOSP POLICY AND LEFT IN THE CONDITION AS WAS USED. THE UNIT WAS TESTED BY CO WHEN NOTIFIED THE NEXT DAY. WITHOUT CHANGING THE SETTINGS ON THE DEVICE AND TAPING THE PROBE TO THE BLANKET, THE UNIT WAS TESTED FOR PROPER OPERATION. THE DEVICE HEATED THE RESERVOIR WATER TO 145 DEGREES FAHRENHEIT. THE TEMP OF THE WATER WAS DETERMINED BY SCANNING THE WATER RESERVOIR WITH AN INFRARED THERMOMETER. THE BLANKET WAS ALSO SCANNED IN THE SAME MANNER AND INDICATED A RANGE OF 136 DEGREES TO 140 DEGREES FAHRENHEIT. THE UNIT CONTINUED TO HEAT PAST THE CONTROLLER SET POINT, CONTINUED TO HEAT WITHOUT THE OVER-TEMPERATURE LIGHT TO COME ON AND SHUT THE UNIT OFF. THIS FAILURE INDICATED THAT THE PRIMARY AND SECONDARY THERMOSTATS DID NOT FUNCTION PROPERLY. THE COMPANY WAS NOTIFIED AND A COMPANY REPRESENTATIVE FOUND A DEFECTIVE THERMOSTAT, WHICH WAS REPLACED. THE BACKUP SAFETY THERMOSTAT WAS THEN RECALIBRATED TO SPECIFICATIONS AND THE SATISFACTION OF THE COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCINNATI SUB ZERO Implant HYPO-HYPERTHERMIA DWJ CINCINNATI SUB ZERO PRODUCTS 200

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization