BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18081

    MDR report key: 20585217 · Received November 1, 2024

    Report

    Report Number
    3003188183-2024-90002
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE, ATTECH 1 MDR NO. 2438477-2022-00082. MDR REPORT CONTENTS: DEVILBISS HEALTHCARE RECEIVED A MEDWATCH REPORT REGARDING AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR, WHICH STATES "PATIENT SMOKING WITH OXYGEN ON AND SUSTAINED SECOND DEGREE BURNS TO FACE." THERE IS NO STATEMENT OR EVIDENCE IN THE REPORT SUGGESTING THE OXYGEN CONCENTRATORMALFUNCTIONED OR IN ANY WAY CAUSED OR CONTRIBUTED TO THE PATIENT INJURY.THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION, AND THE EVIDENCEINDICATES THE ROOT CAUSE OF THE THERMAL DAMAGE TO THE UNIT WAS THE RESULT OF AN EXTERNAL HEAT/FIRE SOURCE, WHICH IS CONSISTENT WITH THE REPORT OF THEPATIENT SMOKING WHILE USING THE OXYGEN CONCENTRATOR.THE UNIT WAS REPAIRED AND IS OPERATING TO SPECIFICATION.". NG Q'TY:1PCS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886272 18081 NEBULIZER CAF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown