BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILBISS

    MDR report key: 11295447 · Received February 8, 2021

    Report

    Report Number
    2515872-2021-00003
    Event Type
    Death
    Date Received
    February 8, 2021
    Date of Event
    December 10, 2020
    Report Date
    January 21, 2021
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304000846
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN AN ENVIRONMENT NOT RECOMMENDED.

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE PRODUCT WHICH IS AN OXYGEN CONCENTRATOR. THE DEVICE WILL NOT BE RETURNED TO US FOR EVALUATION. WE ARE TRYING TO ARRANGE FOR OFF-SITE EVALUATION. THE SERVICE PROVIDER THAT REPORTED THE EVENT TO US ADVISED THAT THE DEVICE WAS NOT THE CAUSE OF THE INJURY OR THE DAMAGE TO THEIR KNOWLEDGE. THE REPORT INDICATED THAT THE PATIENT WAS SMOKING IN THE BED AND CAUSED A FIRE. HIS ROOMMATE SPOTTED THE FIRE AND PULLED THE PATIENT FROM THE BED. THE PATIENT WAS ALIVE AND HAD NO VISIBLE BURN MARKS. THE PATIENT DIED AFTER HE WAS PULLED FROM THE BED. CORONER STATED HE FELT THE PATIENT DIED DUE TO A HEART ATTACK. SO NO AUTOPSY WAS PERFORMED. THE OWNER'S MANUAL AND DEVICE WERE CLEARLY MARKED WITH THE WARNING "NO SMOKING" -DANGER NO SMOKING NEAR PATIENT OR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191972 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1 Death