BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGEN REGULATOR

    MDR report key: 11555074 · Received March 23, 2021

    Report

    Report Number
    3006446479-2021-00002
    Event Type
    Death
    Date Received
    March 23, 2021
    Date of Event
    January 18, 2021
    Report Date
    March 22, 2021
    Manufacturer
    SUNSET HEALTHCARE SOLUTIONS
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT FROM STAFF FOR A CUSTOMER ON OXYGEN THERAPY AT HOME SAW ON A NEWS REPORT THAT A FIRE OCCURRED RESULTING IN DEATH. THE LAST EQUIPMENT KNOWN IN USE INCLUDED AN OXYGEN REGULATOR ITEM NUMBER RES043. NEWS REPORT INDICATES THE FIRE WAS CAUSED BY SMOKING IN THE HOME. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A REPORT FROM STAFF FOR A CUSTOMER ON OXYGEN THERAPY AT HOME SAW ON A NEWS REPORT THAT A FIRE OCCURRED RESULTING IN DEATH. THE LAST EQUIPMENT KNOWN IN USE INCLUDED AN OXYGEN REGULATOR ITEM NUMBER RES043. NEWS REPORT INDICATES THE FIRE WAS CAUSED BY SMOKING IN THE HOME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445672 OXYGEN REGULATOR OXYGEN REGULATOR CAN SUNSET HEALTHCARE SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death