BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 1426565 · Received April 8, 2009

    Report

    Report Number
    1125759-2009-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    January 29, 2009
    Report Date
    April 7, 2009
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A DISPOSABLE PT CIRCUIT.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THE VAPOTHERM PRECISION FLOW HUMIDIFIER'S VAPOR TRANSFER CARTRIDGE (VTC) ALARM WAS ACTIVATED. THEY REMOVED THE DISPOSABLE PT CIRCUIT (DPC) THAT CONTAINED THE VTC, WIPED OFF THE VTC SENSOR WINDOW AND RESTARTED THE UNIT. WATER WAS OBSERVED COMING FROM THE PT'S NOSE. THE PT WAS PLACED ON A CPAP MASK AND GIVEN OXYGEN FROM AN ALTERNATE OXYGEN SOURCE. THE HOSPITAL DID NOT REPORT THE AMOUNT OF WATER INVOLVED IN THE INCIDENT. VAPOTHERM IS NOT AWARE OF ANY PT HARM. THE OPERATING MANUAL INSTRUCTS THE USER TO REMOVE THE CANNULA FROM THE PT WHILE TROUBLESHOOTING AND TO VERIFY THE CANNULA OUTPUT BEFORE REPLACING THE CANNULA ON THE PT. THE USER MAY NOT HAVE FOLLOWED THESE INSTRUCTIONS. ALTHOUGH THE PT WAS NOT HARMED AND THE OPERATING INSTRUCTIONS MAY NOT HAVE BEEN FOLLOWED, VAPOTHERM IS TAKING A CONSERVATIVE APPROACH TO ITS MDR FILING RESPONSIBILITIES BY REPORTING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HUMIDIFIER, RESPIRATORY BTT VAPOTHERM, INC. 080429

    Patients

    Seq Age Sex Outcome Treatment
    1