BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION OXYGEN CONSIVERATOR REGULATOR

    MDR report key: 3554149 · Received December 31, 2013

    Report

    Report Number
    MW5033691
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    December 28, 2013
    Report Date
    December 30, 2013
    Manufacturer
    CHAD/DRIVE INOVO, INC
    Product Code
    NFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REQUIRE OXYGEN 24/7 AND UTILIZE PORTABLE TANKS AND A CHAD/DRIVE EVOLUTION MODEL OM-900 PULSE OXYGEN CONSERVATOR DEVICE WHEN I AM AWAY FROM MY HOUSE. THIS DEVICE (SN (B)(4)) BECAME INTERMITTENT AND FAILED TO PROVIDE OXYGEN IN THE PULSE MODE. I DID NOT REALIZE THAT THE DEVICE WAS MALFUNCTIONING WHILE I WAS WALKING UNTIL I WAS SEVERELY DE-SATURATED AND ABOUT TO PASS OUT. RAPPING THE REGULATOR WITH MY KNUCKLES WOULD TEMPORARILY RESTORE THE FUNCTIONALITY OF THE REGULATOR BUT A FEW MINUTES LATER, THE REGULATOR WOULD AGAIN CEASE TO FUNCTION. THIS IS NOW THE THIRD (3RD) CHAD OM-900 REGULATOR THAT HAS FAILED FOR ME WITH AN IDENTICAL INTERMITTENT CONDITION IN THE PAST YEAR AND NEEDED TO BE REPLACED BY MY OXYGEN PROVIDER. I HAVE CONTACTED MY OXYGEN PROVIDER ((B)(4)) FOR A REPLACEMENT REGULATOR BUT I BELIEVE THE REPETITIVE FAILURE OF THIS MODEL REGULATOR IS DANGEROUS AND A SIGNIFICANT QUALITY ISSUE THAT NEEDS TO BE ADDRESSED. I WANT TO BRING THIS MATTER TO YOUR ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681668 EVOLUTION OXYGEN CONSIVERATOR REGULATOR EVOLUTION OXYGEN CONSIVERATOR REGULATOR NFB CHAD/DRIVE INOVO, INC EVOLUTION OM-900

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening