BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE® PLATINUM® OXYGEN CONCENTRATOR

    MDR report key: 24357522 · Received February 16, 2026

    Report

    Report Number
    3013095415-2026-00061
    Event Type
    Death
    Date Received
    February 16, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 16, 2026
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    CAW
    PMA / PMN Number
    K020386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC LIFE SYSTEMS, INC. D/B/A REACT HEALTH REACHED OUT TO THE PREVIOUS DEVICE MANUFACTURER, INVACARE, FOR AN UPDATE ON THEIR INVESTIGATION. INVACARE¿S GENERAL COUNSEL PROVIDED VENTEC WITH THE FOLLOWING: ¿WE ARE AWARE THAT THE FAMILY CONDUCTED A PRELIMINARY INSPECTION ON FEBRUARY 24, 2026. THE INSPECTION WAS LIMITED TO A VISUAL ASSESSMENT, AND NO EVIDENCE WAS COLLECTED OR REMOVED. OUR COUNSEL ATTENDED ON BEHALF OF INVACARE. AT THAT TIME, PLAINTIFFS¿ COUNSEL INDICATED HE INTENDED TO SCHEDULE A SUBSEQUENT JOINT INSPECTION TO ALLOW ALL INTERESTED PARTIES TO EXAMINE AND COLLECT EVIDENCE; HOWEVER, TO OUR KNOWLEDGE, NO SUCH INSPECTION HAS BEEN SCHEDULED. THERE WERE TWO OXYGEN CONCENTRATORS IN THE RESIDENCE AT THE TIME OF THE FIRE: AN INOGEN UNIT LOCATED IN THE LIVING ROOM, WHERE THE FIRE REPORTEDLY ORIGINATED, AND AN INVACARE UNIT LOCATED IN THE REAR HALLWAY, AWAY FROM THE LIVING ROOM. THE INVACARE UNIT REMAINED PLUGGED IN AT THE TIME OF THE INSPECTION AND APPEARED LARGELY UNDAMAGED. THE DECEDENT WAS A KNOWN HEAVY SMOKER, AND THE AVAILABLE INFORMATION SUGGESTS THE FIRE LIKELY ORIGINATED FROM SMOKING WHILE USING THE INOGEN OXYGEN CONCENTRATOR. WE HAVE NOT RECEIVED ANY COMMUNICATION FROM PLAINTIFFS¿ COUNSEL REGARDING SCHEDULING A FURTHER JOINT INSPECTION, NOR HAVE WE BEEN NOTIFIED OF ANY SUIT BEING FILED.¿ THE INVACARE PLATINUM 10 OXYGEN CONCENTRATOR WAS NOT RETURNED TO INVACARE OR VENTEC FOR AN EVALUATION. BASED ON THE INFORMATION PROVIDED FROM INVACARE IT WAS DETERMINED THAT THE ROOT CAUSE OF THE EVENT WAS DUE TO SMOKING WHILE USING AN OXYGEN CONCENTRATOR THAT WAS NOT MANUFACTURED BY REACT HEALTH. THE INVACARE PLATINUM 10 OXYGEN CONCENTRATOR WAS LOCATED AWAY FROM THE FIRE ORIGIN AND AT THE TIME OF THE INSPECTION APPEARED LARGELY UNDAMAGED.

    Additional Manufacturer Narrative · 0

    H6: THE INITIAL REPORTER DID NOT PROVIDE A DEVICE SERIAL NUMBER FOR THE INVACARE® PLATINUM® 10 OXYGEN CONCENTRATOR. AS A RESULT, SECTION D4, SERIAL #, AND PRIMARY UDI NUMBER ARE CURRENTLY "UNKNOWN," AND SECTION H4, DEVICE MANUFACTURER DATE, SHALL BE LEFT BLANK. IF THE SERIAL NUMBER IS RECEIVED, THESE FIELDS SHALL BE UPDATED ACCORDINGLY. THE DEVICE HAS NOT BEEN RETURNED TO INVACARE OR VENTEC (REACT HEALTH) FOR AN EVALUATION. INVACARE CONTINUES TO INVESTIGATE THE REPORTED ISSUE. ONCE COMPLETE, VENTEC WILL BE PROVIDED WITH THEIR INVESTIGATION FINDINGS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC LIFE SYSTEMS, INC. D/B/A REACT HEALTH, THAT A FIRE HAD OCCURRED IN AN APARTMENT AT AN INDEPENDENT LIVING FACILITY, AND THAT AN INVACARE® PLATINUM® 10 OXYGEN CONCENTRATOR WAS LOCATED IN THE AREA WHERE THE FIRE APPEARED TO HAVE STARTED. SHORTLY AFTER THE INITIAL NOTIFICATION, VENTEC WAS CONTACTED BY THE PREVIOUS DEVICE MANUFACTURER, INVACARE, WHO HAD ALSO BEEN CONTACTED. INVACARE HAD BEEN SENT A LETTER WHICH ADVISED OF THE FOLLOWING: ¿A FIRE OCCURRED IN AN APARTMENT ON (B)(6) 2026, RESULTING IN THE DEATH OF TWO ADULTS. AT THIS POINT, I DO NOT POSSESS A LOT OF DETAILS, BUT IT IS MY UNDERSTANDING THE FIRE ORIGINATED IN THE LIVING ROOM AREA. AN INVACARE PLATINUM 10 OXYGEN CONCENTRATOR WAS LOCATED IN THE AREA WHERE THE FIRE APPEARS TO HAVE STARTED. TO BE CLEAR, NO ONE HAS OPINED THE INVACARE OXYGEN CONCENTRATOR STARTED THE FIRE AND THERE WAS AN ELECTRIC SCOOTER AND ANOTHER OXYGEN CONCENTRATOR (MANUFACTURED BY ANOTHER COMPANY) IN THE AREA AS WELL.¿ INVACARE FURTHER ADVISED THAT THEIR GENERAL COUNSEL CONTACTED THE LAWYER WHO HAD SENT THE LETTER, REQUESTING ADDITIONAL INFORMATION. THE LAWYER ADVISED INVACARE¿S GENERAL COUNSEL THAT HE WOULD TRY TO OBTAIN THE SERIAL NUMBER FOR THE INVACARE PLATINUM 10 OXYGEN CONCENTRATOR, AND THAT THE SECOND OXYGEN CONCENTRATOR IN THE ROOM WAS AN INOGEN ONE. THE LAWYER STATED THAT THE TWO ADULTS WHO DIED IN THE FIRE WERE HUSBAND AND WIFE, AND THAT THE WIFE WAS A HEAVY SMOKER. THE WIFE¿S BODY WAS FOUND IN THE LIVING ROOM WHERE THE FIRE ORIGINATED AND HER HUSBAND WAS FOUND IN THE BACK BEDROOM. THE DECEASED HAD BEEN RESIDENTS OF THE FACILITY FOR APPROXIMATELY 5-6 YEARS PRIOR TO THE FIRE. THE LAWYER FURTHER ADVISED THAT INSPECTORS FROM THE LOCAL FIRE DEPARTMENT AS WELL AS THOSE HIRED BY THE FACILITY HAD ALREADY BEEN TO THE RESIDENCE. THE LAWYER FURTHER ADVISED INVACARE¿S GENERAL COUNSEL THAT AT THIS TIME HE WAS NOT AWARE OF ANY ALLEGATIONS THAT THE FIRE WAS CAUSED BY MALFUNCTIONS OF EITHER OXYGEN CONCENTRATOR. THIS MEDWATCH REPORT IS TO DOCUMENT THE DEATH OF THE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171733 INVACARE® PLATINUM® OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW INVACARE TAYLOR STREET IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1