BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILBISS

    MDR report key: 12250471 · Received July 29, 2021

    Report

    Report Number
    2515872-2021-00008
    Event Type
    Death
    Date Received
    July 29, 2021
    Date of Event
    April 28, 2020
    Report Date
    August 3, 2021
    Manufacturer
    DEVILBISS HEALTHCARE, LLC.
    Product Code
    CAW
    UDI-DI
    00885304014492
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE, LLC. IS THE MANUFACTURER OF THE DEVILBISS MODEL 525DS OXYGEN CONCENTRATOR. WE WERE NOTIFIED OF THIS INCIDENT AND ARE FILING THIS REPORT WITH LIMITED DATA. THE INFORMATION WE RECEIVED TO DATE STATES THERE WAS A FATAL HOME FIRE INCIDENT, IN WHICH THE DECEASED WAS USING AN OXYGEN CONCENTRATOR. THE CAUSE OF THE FIRE IS UNKNOWN. THE CONCENTRATOR WAS DESTROYED IN THE INCIDENT AND CANNOT BE EVALUATED. THE INCIDENT IS UNDER FURTHER INVESTIGATION. WE WILL SUBMIT A FOLLOW-UP REPORT ONCE ADDITIONAL DATA IS OBTAINED.

    Description of Event or Problem · 1

    DEVILBISS HEALTHCARE, LLC. IS THE MANUFACTURER OF THE DEVILBISS MODEL 525DS OXYGEN CONCENTRATOR. WE WERE NOTIFIED OF THIS INCIDENT AND ARE FILING THIS REPORT WITH LIMITED DATA. THE INFORMATION WE RECEIVED TO DATE STATES THERE WAS A FATAL HOME FIRE INCIDENT, IN WHICH THE DECEASED WAS USING AN OXYGEN CONCENTRATOR. THE CAUSE OF THE FIRE IS UNKNOWN. THE CONCENTRATOR HAS NOT BEEN RETRIEVED FOR EVALUATION. THE INCIDENT IS UNDER FURTHER INVESTIGATION. WE WILL SUBMIT A FOLLOW-UP REPORT ONCE ADDITIONAL DATA IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146850 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE, LLC. 525DS 00885304014492

    Patients

    Seq Age Sex Outcome Treatment
    1 Death