BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL 1® EQUATOR® CONVECTIVE WARMING ACCESSORY

    MDR report key: 8693650 · Received June 12, 2019

    Report

    Report Number
    3012307300-2019-03208
    Event Type
    Injury
    Date Received
    June 12, 2019
    Report Date
    March 20, 2020
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    DWJ
    PMA / PMN Number
    K011907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS SLIGHTLY DIRTY BUT IN GOOD CONDITION. THE HOSE (#SW5-HOSE-7) WAS DAMAGED. THE POWER CORD (#6051008) WAS NOT THE ORIGINAL ONE. WHEN TESTED HOWEVER THE VALUES WERE FOUND TO BE ACCEPTABLE. THE DEVICE PASSED THE INITIAL SELF-TEST. THE INVESTIGATOR THEN SELECTED FOR DIFFERENT TEMPERATURES. THE DEVICE INITIALLY WORKED AS INTENDED. THE HOSE SENSOR CABLE WAS THEN MANIPULATED TO SEE IF THE PRODUCT PROBLEM COULD BE REPLICATED. NO ISSUES WERE IDENTIFIED. THE DEVICE PASSED ALL THE FUNCTIONAL TESTS. NO FAULT WAS FOUND WITH THE DEVICE.

    Description of Event or Problem · 0

    DEVICE ANALYSIS COMPLETED AND UPDATED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT SECOND DEGREE AND THIRD DEGREE BURNS WERE NOTED TO THE PATIENT'S TOES FOLLOWING USE OF A LEVEL 1® EQUATOR® CONVECTIVE WARMING HOSE. THE PATIENT WAS REPORTED TO HAVE BEEN LYING FLAT ON HIS BACK DURING THE PROCEDURE. JELONET DRESSINGS AND FLAMMAZINE CREAM WERE USED FOR THE TREATMENT OF THE BURNS. PROLONGED SEDATION AND IMMOBILIZATION WITH EXTENDED HOSPITAL STAY WAS REPORTED. THERE WAS NO FURTHER REPORTED ADVERSE EFFECTS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE BURNED A PATIENT. THERE WERE NO REPORTED FURTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484235 LEVEL 1® EQUATOR® CONVECTIVE WARMING ACCESSORY SYSTEM, THERMAL REGULATING DWJ SMITHS MEDICAL ASD; INC. N2068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R