BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 12009577 · Received June 16, 2021

    Report

    Report Number
    2518422-2021-01717
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 16, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    UDI-DI
    00606959014954
    PMA / PMN Number
    K061261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUGHT ON FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND WAS FOUND TO HAVE EVIDENCE OF THERMAL DAMAGE. THE THERMAL DAMAGE WAS CAUSED BY COMPONENTS ON THE MAIN BOARD. THE DEVICE HAD EVIDENCE OF PHYSICAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903846 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC. 1020000 00606959014954

    Patients

    Seq Age Sex Outcome Treatment
    1