BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 18016213 · Received October 26, 2023

    Report

    Report Number
    2438477-2023-00137
    Event Type
    Death
    Date Received
    October 26, 2023
    Date of Event
    January 11, 2022
    Report Date
    October 26, 2023
    Manufacturer
    DANYANG AIRTECH CO., LTD
    Product Code
    CAN
    UDI-DI
    00822383143170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN REGULATOR INVOLVED IN AN IGNITION EVENT BY A LETTER FROM AN ATTORNEY, WHICH ALLEGES THAT THE RESULTING FIRE WAS CAUSED BY AN ALLEGED DEFECT IN THE REGULATOR. THE FIRE RESULTED IN PROPERTY DAMAGE. ALTHOUGH A DEATH WAS REPORTED, THE MEDICAL EXAMINER DID NOT ATTRIBUTE THE DEATH TO THE DEVICE. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023346 DRIVE DEVILBISS HEALTHCARE REGULATOR, PRESSURE, GAS CYLINDER CAN DANYANG AIRTECH CO., LTD 18302GDEL 00822383143170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death