BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVILBISS

    MDR report key: 10835889 · Received November 13, 2020

    Report

    Report Number
    2515872-2020-00002
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 11, 2020
    Report Date
    November 13, 2020
    Manufacturer
    DEVILBIIS HEALTHCARE
    Product Code
    CAW
    UDI-DI
    00885304016991
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN AN ENVIRONMENT NOT RECOMMENDED. IF THE DEVICE IS RETURNED IT WILL BE EVALUATED FOR ROOT CAUSE.

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE WHICH IS AN OXYGEN CONCENTRATOR. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WHEN IT BECOMES AVAILABLE WE WILL FILE A FOLLOW-UP REPORT. THE END-USER WAS SMOKING WHILE USING OXYGEN AND FELL BACK ASLEEP. IT IS BELIEVED THE CIGARETTE FELL ONTO THE DEVICE AND CAUGHT FIRE. THE USER ACQUIRED BURNS AND WAS TAKEN TO THE BURN UNIT AT THE HOSPITAL FOR TREATMENT. SHE WAS RELEASED. THE USER MANUAL AND LABELING ON THE DEVICE WARN AGAINST USE OF THE DEVICE WHILE SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300356 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBIIS HEALTHCARE 525DS 00885304016991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other