BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVILBISS

    MDR report key: 10750105 · Received October 28, 2020

    Report

    Report Number
    2515872-2020-00001
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 28, 2020
    Manufacturer
    DEVILBISS HEALTHCARE, LLC
    Product Code
    CAW
    UDI-DI
    00885304016991
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS THE DISTRIBUTOR OF THE DEVICE WHICH IS A PORTABLE OXYGEN GENERATOR.. DEVILBISS HEALTHCARE, LLC , A SUBSIDIARY OF DRIVE DEVILBISS, IS THE DEVICE MANUFACTURER. DEVILBISS HAS RETRIEVED THE DEVICE FOR EVALUATION. WE WILL FILE A FOLLOW-UP REPORT WHEN THE EVALUATION IS COMPLETED. THE UNIT WAS IN USE. THE END-USER DROPPED A CIGARETTE ON THE UNIT. THERE WAS A REACTION TO THE CIGARETTE. THE END-USER WAS TAKEN TO THE HOSPITAL. DIAGNOSIS AND TREATMENT UNKNOWN AT THIS TIME. THE MANUAL AND WARNING LABELS ON THE DEVICE INDICATE "NO SMOKING ALLOWED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217342 DEVILBISS PORTABLE OXYGEN GENERATOR CAW DEVILBISS HEALTHCARE, LLC 525DS 00885304016991

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization