BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 4856739 · Received June 19, 2015

    Report

    Report Number
    1040777-2015-00032
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    June 7, 2015
    Report Date
    June 12, 2015
    Manufacturer
    RESPIRONICS INC
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS COMPLETED THE INVESTIGATION OF AN MILLENNIUM OXYGEN CONCENTRATOR THAT WAS ALLEGEDLY INVOLVED IN A HOUSE FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS EVALUATED BY (B)(4) SUPPLIER. THE (B)(4) COULD FIND NO EVIDENCE TO INDICATE THAT THE CONCENTRATOR WAS THE CAUSE OF THE FIRE. THE (B)(4) TESTED THE DEVICE AND FOUND THE DEVICE TO OPERATE AND ALARM TO DESIGN SPECIFICATIONS. THE MANUFACTURER CONCLUDES THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE SOURCE OF THE FIRE WAS DUE TO AN EXTERNAL SOURCE, THE DEVICE DID NOT CAUSE THE HOUSE FIRE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO CHANGE TO THE INITIAL REPORT THAT WAS FILED AS MDR 1040777-2015-00032.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUSED A HOUSE FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE TECHNICIAN FOUND NO EVIDENCE OF THERMAL DAMAGE INTERNAL OR EXTERNAL TO THE DEVICE. THE DEVICE'S POWER CORD WAS OBSERVED TO HAVE ITS INSULATION MELTED, HOWEVER THE POWER CORD CONTINUED TO PROVIDE AC POWER TO THE DEVICE. THE POWER CORD WAS REPLACED DUE TO COSMETIC ISSUES. THE DEVICE OPERATED AND ALARMED TO DESIGN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399307 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS INC 1020000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR