BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ-5000 EQUATOR CONVECTIVE WARMER

    MDR report key: 4863012 · Received June 19, 2015

    Report

    Report Number
    2183502-2015-00435
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 18, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K011907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE UNIT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE UNIT TO BE IN VERY USED CONDITION. FURTHER INSPECTION FOUND THE FILTER WAS IN NEED OF REPLACEMENT AND WAS FULL OF LINT AND OTHER DEBRIS. THE INSIDE OF THE UNIT ALSO HAD LINT AND OTHER DEBRIS AND SIGNS OF FLUID INGRESSION. A SCREW WAS FOUND INSIDE THE UNIT FREE FLOATING AND NOT IN THE DESIGNED LOCATION. MAINTENANCE WAS VERY POOR FOR THIS UNIT. THE HOSE THAT WAS RETURNED WITH THIS UNIT WAS ALSO FOUND TO BE IN VERY POOR CONDITION AND THE HOSE ITSELF HAD AN AREA MID-LENGTH THAT WAS CRUSHED DOWN AND NO LONGER CIRCULAR. THE HOSE ELBOW WAS CRACKED AND MISSING PARTS OF THE INPUT PORTION. THE HOSE SHOWED EVIDENCE OF SUSTAINING SIGNIFICANT ABUSE. DEVICE WAS MECHANICALLY TESTED WITH RETURNED HOSE AND POWER CORD FOR OVER A 10 HOUR PERIOD TESTING FOR ALL 3 TEMPERATURE SET POINTS. UNIT PASSED ALL FUNCTIONAL TESTING. UNIT TURNED ON AND COMPLETED SELF-TEST AS EXPECTED. NO FAULT FOUND WITH THE OPERATION OF THE RETURNED UNIT. UNIT OPERATED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH A PATIENT DURING A SURGICAL PROCEDURE FOR 3 HOURS. ACCORDING TO REPORTER, THE PATIENT SUSTAINED BURNS TO LEFT THIGH AFTER DEVICE USE. THE CLINICIAN DIDN'T PRESCRIBE ANY SPECIAL TREATMENT, ONLY MONITORING AND HYDRATION IF NECESSARY. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401320 EQ-5000 EQUATOR CONVECTIVE WARMER DWJ SMITHS MEDICAL ASD, INC. EQ-5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other