BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 9758003 · Received February 26, 2020

    Report

    Report Number
    2518422-2020-00465
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 4, 2020
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN OXYGEN CONCENTRATOR WAS ALLEGEDLY INVOLVED IN A HOUSE FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. REPEATED ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH, MW 5092560, THAT STATED AN OXYGEN CONCENTRATOR WAS INVOLVED IN A HOUSE FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218286 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC. 1020000

    Patients

    Seq Age Sex Outcome Treatment
    1