BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLO

    MDR report key: 20925088 · Received December 13, 2024

    Report

    Report Number
    2518422-2024-105504
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 3, 2024
    Report Date
    April 23, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    UDI-DI
    00606959014954
    PMA / PMN Number
    K061261
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED A VOLUNTARY MEDWATCH (B)(4) IN REFERENCE TO AN EVERFLO OXYGEN CONCENTRATOR. THE USER WAS SMOKING IN BED WHILE USING THE EVERFLO OXYGEN CONCENTRATOR ON (B)(6) 2024, RESULTING IN IGNITION (UNSPECIFIED FUEL SOURCE). THE PATENT'S GRANDDAUGHTER WAS REPORTED TO HAVE SMOTHERED THE FIRE WITH A BLANKET. THE FOLLOWING DAY THE PATIENT'S HOMECARE NURSE ASSESSED THE PATIENT NOTING RIGHT UPPER THIGH AND NASAL BURNS (REPORTED 2ND DEGREE). FURTHER MEDICAL EVALUATION VIA EMS WAS DECLINED AND THE PATIENT WAS REPORTED TO HAVE RECEIVED TRIPLE ANTIBIOTIC OINTMENT FOR THE WOUNDS. DESPITE THREE GOOD FAITH EFFORT ATTEMPTS, THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE COMPLETED. IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED FAILURE OF THERMAL ISSUE IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION FIRE, FLAME, SMOKE. COMPLAINTS FOR THIS FAILURE ARE REVIEWED VIA THE POST MARKET COMPLAINT TRENDING AND ESCALATION PROCESSES TO ASSESS FOR THE OBSERVED PROBABILITY LEVELS AND COMPARE THEM WITH THE PREDICTED LEVELS IN THE RISK FILE FOR THE HAZARDS LINKED TO THE FAILURE. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO FURTHER INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAS LED TO UNACCEPTABLE INCREASE IN PROBABILITY LEVELS FOR THE HAZARDOUS SITUATIONS IN SCOPE, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. QA CONTINUES TO MONITOR COMPLAINTS FOR THIS ISSUE PER THE CADENCE IN THE COMPLAINT TRENDING PROCEDURES. THE DEVICE MENTIONED IN THIS COMPLAINT HAS EXCEEDED ITS USEFUL LIFE PER THE APPLICABLE IFU.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED A VOLUNTARY MEDWATCH (120535-2024-0001) IN REFERENCE TO AN EVERFLO OXYGEN CONCENTRATOR. THE USER WAS SMOKING IN BED WHILE USING THE EVERFLO OXYGEN CONCENTRATOR ON (B)(6) 2024, RESULTING IN IGNITION (UNSPECIFIED FUEL SOURCE). THE PATENT'S GRANDDAUGHTER WAS REPORTED TO HAVE SMOTHERED THE FIRE WITH A BLANKET. THE FOLLOWING DAY THE PATIENT'S HOMECARE NURSE ASSESSED THE PATIENT NOTING RIGHT UPPER THIGH AND NASAL BURNS (REPORTED 2ND DEGREE). FURTHER MEDICAL EVALUATION VIA EMS WAS DECLINED AND THE PATIENT WAS REPORTED TO HAVE RECEIVED TRIPLE ANTIBIOTIC OINTMENT FOR THE WOUNDS. THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2024-105504 STATING VOLUNTARY MEDWATCH, 120535-2024-0001, WAS RECEIVED IN REFERENCE TO AN EVERFLO CONCENTRATOR. THE MANUFACTURER DID NOT INCLUDE THIS RELATED REPORT NUMBER IN H10 ON THE PREVIOUS REPORT. THE MANUFACTURER IS SUBMITTING A CORRECTION TO INCLUDE VOLUNTARY MEDWATCH 120535-2024-0001 IN H10. SECTION H10 HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (120535-2024-0001) IN REFERENCE TO AN EVERFLO OXYGEN CONCENTRATOR. THE USER WAS SMOKING IN BED WHILE USING THE EVERFLO OXYGEN CONCENTRATOR ON (B)(6) 2024, RESULTING IN IGNITION (UNSPECIFIED FUEL SOURCE). THE PATENT'S GRANDDAUGHTER WAS REPORTED TO HAVE SMOTHERED THE FIRE WITH A BLANKET. THE FOLLOWING DAY THE PATIENT'S HOMECARE NURSE ASSESSED THE PATIENT NOTING RIGHT UPPER THIGH AND NASAL BURNS (REPORTED 2ND DEGREE). FURTHER MEDICAL EVALUATION VIA EMS WAS DECLINED AND THE PATIENT WAS REPORTED TO HAVE RECEIVED TRIPLE ANTIBIOTIC OINTMENT FOR THE WOUNDS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215838 EVERFLO GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1020000 00606959014954

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Life Threatening