BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16421609 · Received February 22, 2023

    Report

    Report Number
    2438477-2023-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Report Date
    February 22, 2023
    Manufacturer
    GLOBALCARE MEDICAL TECHNOLOGY HK, LTD.
    Product Code
    BTI
    UDI-DI
    00822383579153
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY AN END USER, WHO STATED THAT "WHILE I WAS USING IT, IT POPPED, A LITTLE FIRE SHOT OUT AND IT STARTED SMOKING." 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
    263799 DRIVE NEBULIZER BTI GLOBALCARE MEDICAL TECHNOLOGY HK, LTD. MQ5800 00822383579153

    Patients

    Seq Age Sex Outcome Treatment
    1 Male