BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 11820696 · Received May 13, 2021

    Report

    Report Number
    2518422-2021-01440
    Event Type
    Death
    Date Received
    May 13, 2021
    Date of Event
    May 10, 2021
    Report Date
    July 7, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    UDI-DI
    00606959032576
    PMA / PMN Number
    K061261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A PATIENT ALLEGEDLY EXPIRED WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND THE DEVICE WAS FOUND TO HAVE EVIDENCE OF PHYSICAL DAMAGE. THE DEVICE WAS TESTED AND WAS FOUND TO OPERATE AND ALARM TO DESIGN SPECIFICATIONS. THE MANUFACTURER CONCLUDES THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716048 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC. 1020008 00606959032576

    Patients

    Seq Age Sex Outcome Treatment
    1 Death