BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXLIFE INDEPENDENCE

    MDR report key: 16673785 · Received April 3, 2023

    Report

    Report Number
    MW5116246
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 29, 2023
    Manufacturer
    O2 CONCEPTS, LLC
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EQUIPMENT MALFUNCTION PATIENT UTILIZATION. THE UNIT WAS TESTED AND THE PURITY WAS FLUCTUATING FROM 90%-85% AND 85%-90% INDICATING 1 OF THE SIEVE BEDS MAY BE DEFECTIVE, THE UNIT WAS NOT ALARMING. THE UNIT WILL BE SENT IN TO THE MANUFACTURER FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242140 OXLIFE INDEPENDENCE GENERATOR, OXYGEN, PORTABLE CAW O2 CONCEPTS, LLC 301-0001V

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization