BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ-5000 EQUATOR CONVECTIVE WARMER

    MDR report key: 3981464 · Received July 25, 2014

    Report

    Report Number
    2183502-2014-00523
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 22, 2014
    Report Date
    July 24, 2014
    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

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVAL 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 EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED DEVICE WAS IN USE WITH PT FOR AN UNK AMOUNT O TIME WHEN THE DEVICE ALARMED. THE DEVICE DISPLAYED 48 DEGREES CELSIUS. THE DEVICE WAS STOPPED AND THE PT'S SKIN WAS OBSERVED TO BE RED. THE FOLLOWING DAY THE SURGEON EXAMINED THE PT'S SKIN AND THE REDNESS HAD SUBSIDED. NO PERMANENT ADVERSE EFFECTS TO PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437098 EQ-5000 EQUATOR CONVECTIVE WARMER DWJ - CONVECTIVE WARMER DWJ SMITHS MEDICAL ASD, INC EQ-5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other