BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6910P-DR

    MDR report key: 20585204 · Received November 1, 2024

    Report

    Report Number
    3003188183-2024-90003
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    March 3, 2023
    Report Date
    March 6, 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. 2438477-2022-00112MDR REPORT CONTENTS:DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PORTABLE COMPRESSOR NEBULIZER BY A DISTRIBUTOR, WHO STATED THE "UNIT IS SPARKINGAT THE TUBING CONNECTOR WHEN POWERING ON." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THECOMPLAINT.DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IFADDITIONAL INFORMATION BECOMES AVAILABLE.NG Q'TY:1PCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930016 6910P-DR NEBULIZER BTI VEGA TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown