BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS HEALTHCARE

    MDR report key: 11203379 · Received January 20, 2021

    Report

    Report Number
    2515872-2021-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    January 3, 2021
    Report Date
    January 20, 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

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE LLC IS THE MANUFACTURER OF THE DEVICE WHICH IS A OXYGEN CONCENTRATOR. WE HAVE NOT RETRIEVED THE DEVICE FOR EVALUATION HOWEVER IT HAS BEEN ISOLATED BY THE SERVICE PROVIDER. WE ARE FILING THIS REPORT TO MEET TIMELINES. WE WILL FILE A FOLLOW-UP AS DATA BECOMES AVAILABLE. USER WAS TAKING A NAP WHILE DEVICE WAS IN SERVICE. THE USER'S FAMILY REPORTED THAT THE NASAL CANNULA CAUGHT FIRE CAUSING BURNS TO THE FACE. DUE TO HIPPA RESTRICTIONS NO FURTHER DETAILS REGARDING THE USER OR MEDICAL TREATMENT WERE PROVIDED. HOWEVER THE SERVICE PROVIDER HAS INDICATED THAT THE DEVICE WAS NOT NAMED AS THE CAUSE OF ANY INJURY OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98874 DEVILBISS HEALTHCARE OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 525DS 00885304000846

    Patients

    Seq Age Sex Outcome Treatment
    1