BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 11812498 · Received May 12, 2021

    Report

    Report Number
    2518422-2021-01306
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    March 15, 2021
    Report Date
    July 14, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    PMA / PMN Number
    K062161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED 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 NO EVIDENCE OF THERMAL DAMAGE. THE DEVICE WAS TESTED AND WAS FOUND TO OPERATE TO DESIGN SPECIFICATIONS.

    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 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
    710762 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1