BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAOPTHERM 2000I

    MDR report key: 667258 · Received January 17, 2006

    Report

    Report Number
    1125759-2005-00007
    Event Type
    Other
    Date Received
    January 17, 2006
    Date of Event
    February 8, 2005
    Report Date
    January 16, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP STAFF CONNECTED THE VAPOTHERM DEVICE TO AN OXYGEN FLOW METER RATHER THAN AN OXYGEN BLENDER. BOTH METHODS CAN BE USED. HOWEVER, IF THE PRESCRIBED LEVEL OF OXYGEN IS NOT 100%, BLENDED GAS CAN BE PROVIDED USING A MEDICAL GAS BLENDER. IN THIS CASE, THE PT MAY HAVE BEEN INAPPROPRIATELY CONNECTED TO AN OXYGEN FLOW METER RATHER THAN A BLENDER. ACCORDING TO RISK MGR FOR HOSP, IN A TELEPHONE INTERVIEW, THE HOSP STAFF CONNECTED THE VAPOTHERM INCORRECTLY FOR THIS PARTICULAR SET-UP BUT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAOPTHERM 2000I HUMIDIFIER BTT VAPOTHERM, INC. 2000I UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other