BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEVILBISS OXYGEN CONSERVING DEVICE

    MDR report key: 2921920 · Received January 10, 2013

    Report

    Report Number
    2515872-2013-00003
    Event Type
    Other
    Date Received
    January 10, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 10, 2013
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    NFB
    PMA / PMN Number
    K020329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "(B)(6) HAS STATED THAT THE PT IS UNWILLING TO ALLOW THEM TO PICK UP THE EQUIPMENT FOR ASSESSMENT. APPARENTLY THE PT HAD BEEN USING THE CYLINDER AND CONSERVING DEVICE WITHOUT ISSUE EARLIER IN THAT SAME DAY. AT THIS POINT WE ARE UNABLE TO PROCEED WITH ANY FURTHER INVESTIGATION UNTIL THE EQUIPMENT IS RETRIEVED BY (B)(6). (B)(6) HAS NOTIFIED THE PT THAT WE WILL BE UNABLE TO FURTHER INVESTIGATE THIS INCIDENT WITHOUT EVALUATING THE EQUIPMENT."

    Description of Event or Problem · 1

    END USER STATED SHE WAS AT HOME AND PLACED HER OCD (OXYGEN CONSERVING DEVICE) ON A FRESH B-TANK AROUND 3:30 PM ON (B)(6) 2012. END USER APPROXIMATED THE TIME AS SHE WAS NOT EXACTLY SURE WHEN THIS INCIDENT OCCURRED. WHEN SHE TOOK HER FIRST BREATH FROM THE NEW TANK, SHE STATED SHE FELT A SLOW BURN. SHE WENT TO INSTALL ANOTHER TANK AND TOOK A SECOND BREATH FROM THE CURRENT O2 SETUP. THE SECOND BREATH ALSO CAUSED A BURNING, WHICH SHE DESCRIBED AS BREATHING IN ACID AND THAT THE SMELL WAS HARSH. SHE WAS ABLE TO BRING HER DOG BACK INSIDE HER HOME AND CALLED 911 BEFORE PASSING OUT. SHE WAS TAKEN BY AMBULANCE TO THE HOSPITAL WHERE SHE STATED SHE WAS PLACED ON A VENTILATOR AS PART OF HER TREATMENT. THE LOCAL BRANCH MADE SEVERAL ATTEMPTS TO RECOVER AND QUARANTINE THE EQUIPMENT INVOLVED BUT THE END USER IS REFUSING TO RETURN THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14952 DEVILBISS OXYGEN CONSERVING DEVICE PULSE DOSE NFB DEVILBISS HEALTHCARE LLC PD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other