BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 15419206 · Received September 14, 2022

    Report

    Report Number
    2438477-2022-00069
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    July 13, 2022
    Report Date
    September 14, 2022
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    CAF
    UDI-DI
    00822383504131
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY THE PATIENT, WHO STATED THAT THE "NEBULIZER CAUGHT ON FIRE AND HE IMMEDIATELY PULLED THE POWER CORD AND THREW THE NEBULIZER OUT THE DOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2643244 DRIVE NEBULIZER CAF VEGA TECHNOLOGIES INC. 18081 00822383504131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown