BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE

    MDR report key: 8133316 · Received December 5, 2018

    Report

    Report Number
    3012307300-2018-08718
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    April 26, 2018
    Report Date
    December 4, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CONVECTIVE WARMING EQUATOR BLOWER WAS RETURNED FOR EVALUATION. DEVICE WAS RECEIVED IN FAIR CONDITION WITH HOSE AND POWER CORD, AND UNDERWENT FUNCTIONAL TESTING. TEMPERATURE ALARM TEST SET AT 36, 40, AND 44 DEGREES. DEVICE HAD ALARMED OVER TEMPERATURE AT 39, 42 AND 46 DEGREES, MEETING SPECIFICATIONS. WHEN DEVICE WAS SET TO 40 DEGREES, THE CONTROL BOARD BLEW. THE FUSE WAS REPLACED. WHEN TEMPERATURE WAS SET TO 44 DEGREES FOR 2.5 HOURS, AND MEASURED TEMPERATURE WAS 45.50 DEGREES. FOUND TEMPERATURE SET POINTS FOUND TO BE OUT OF TOLERANCE. CALIBRATION REQUIRED. REPORTED CUSTOMER COMPLAINT WAS CONFIRMED. WHILE NO DEFINITIVE ROOT CAUSE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING AN ABDOMINOPERINEAL AMPUTATION, A SMITHS MEDICAL CONVECTIVE WARMING EQUATOR BLOWER HEATED TO 48 DEGREES INSTEAD OF HEATING TO 44 DEGREES. TRACES OF BURNS AND PHLYCTENE THAT OCCURRED ON THE ARM AND CHEST OF THE PATIENT. INTERVENTION INCLUDED THE USE OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973034 LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING DWJ SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention