BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMISCOPE

    MDR report key: 20585209 · Received November 1, 2024

    Report

    Report Number
    3003188183-2024-90007
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    BTI
    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 AS ATTACHMENT 1 MDR NO.:2428983-2014-00003. MDR REPORT CONTENTS[?]END USER STATED THAT SHE WAS USING HER 5710 NEBULIZER WHEN SHE NOTICED THAT THE TOWEL THAT SHE HAS BETWEEN THE UNIT AND HER TABLE WAS ON FIRE. SHE ALSO CLAIMS THAT SHE SAW FLAMES COMING FROM THE BACK OF THE UNIT. SHE USED SOME WATER THAT SHE HAD SITTING CLOSE TO HER TO EXTINGUISH THE FIRE. NO INJURY WAS ASSOCIATED WITH THIS PRODUCT MALFUNCTION. NG Q'TY: (B)(4) PCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930021 LUMISCOPE NEBULIZER BTI VEGA TECHNOLOGIES INC. CN-02WD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown