BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILBISS

    MDR report key: 12355560 · Received August 23, 2021

    Report

    Report Number
    2515872-2021-00012
    Event Type
    Death
    Date Received
    August 23, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 20, 2021
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304022466
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE WHICH IS AN OXYGEN CONCENTRATOR. WE HAVE NOT RETRIEVED THE DEVICE FOR INVESTIGATION. IT IS BEING HELD IN A CRIMINAL INVESTIGATION. WE WILL FILE AN UPDATE WHEN WE RETRIEVE THE PRODUCT FOR EVALUATION. A FIRE OCCURRED IN THE END-USERS HOME WHICH ULTIMATELY LEAD TO HER DEATH. THE DATE OF LOSS IS ON (B)(6) 2021. CURRENTLY BOTH THE FIRE DEPARTMENT AND AN INSURANCE COMPANY ARE INVESTIGATING THE SCENE. AS SUCH, THE UNIT WILL NOT BE AVAILABLE FOR RETURN UNTIL THEIR INVESTIGATIONS ARE COMPLETE. CURRENTLY THE FIRE DEPUTY HAS NOT NAMED THE OXYGEN CONCENTRATOR AS A SUSPECT IN THE FIRE BUT THE INVESTIGATION IS STILL PENDING. THE USER AND SPOUSE ARE HEAVY PACK A DAY CIGARETTE SMOKERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252584 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 1025DS 00885304022466

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death