BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQ-5000 EQUATOR CONVECTIVE WARMER

    MDR report key: 929811 · Received October 19, 2007

    Report

    Report Number
    1221261-2007-00050
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Report Date
    September 21, 2007
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE EVENT UNIT WAS RETURNED FOR INVESTIGATION. THE UNIT FUNCTION WAS TESTED BY OUR ENGINEERS TO TRY TO REPRODUCE THE CUSTOMER REPORT. THE RETURNED UNIT FUNCTIONED AS INTENDED. WE WERE UNABLE TO FIND A DEVICE MALFUNCTION THAT WOULD EXPLAIN THEIR REPORT. REVIEW OF INSTRUCTIONS FOR USE CAUTIONS: THERMAL INJURY MAY OCCUR IF THESE CAUTIONS ARE NOT FOLLOWED: THE CAUTIONS STATE: OBSERVE PT BODY CORE TEMPERATURE AND CUTANEOUS RESPONSE UNDER/NEXT TO THE BLANKET. INCREASE THE TEMPERATURE SETTING IF REQUIRED, USING CORE BODY TEMP AS AN INDICATOR. OBSERVE CUTANEOUS RESPONSE; IF ERYTHEMA APPEARS, DECREASE THE TEMP SETTING OR DISCONTINUE THERAPY. DO NOT LEAVE PTS UNMONITORED DURING PROLONGED WARMING THERAPY SESSIONS. MONITOR PT'S TEMP AND VITA SIGNS, AND OBSERVE CUTANEOUS RESPONSE AT REGULAR INTERVALS. IN HYPOTENSIVE AND HYPOPERFUSED PTS, OBSERVE CUTANEOUS RESPONSE MORE FREQUENTLY. REDUCE THE TEMP SETTING OR DISCONTINUE USE IF INSTABILITY IN VITAL SIGNS OR ERYTHEMA OCCURS. USE ONLY CONVECTIVE WARMING BLANKETS MANUFACTURED AND/OR APPROVED BY SMITHS MEDICAL. DO NOT ALLOW THE PT'S ARMS OR LEGS TO REST ON THE ACTIVE HOSE INLET AS THERMAL INJURY MAY OCCUR. WITHOUT THE FACILITY RESPONDING TO EVENT QUESTIONS, WE DO NOT KNOW WHAT BLANKET WAS USED, WHERE THE BURN WAS ON THE PT, OR IF ANY TREATMENT WAS NEEDED. ROOT CAUSE: THE ROOT CAUSE OF THIS EVENT WAS LIKELY USER INTERFACE OF NOT MONITORING THE PT DURING USE PER THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    USER ALLEGES THAT THE PT WAS BURNED DUE TO THE OVER TEMPERATURE ALARM NOT ALARMING. UNIT WAS DISPLAYING 12-13 DEGRESS BUT HEATED TO 54 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQ-5000 EQUATOR CONVECTIVE WARMER 74 DWJ CONVECTIVE WARMER DWJ SMITHS MEDICAL ASD, INC. 20050579

    Patients

    Seq Age Sex Outcome Treatment
    1 YR