BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 1426564 · Received April 8, 2009

    Report

    Report Number
    1125759-2009-00005
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    February 25, 2009
    Report Date
    April 7, 2009
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE WATER CIRCUIT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE PRECISION FLOW UNIT DID NOT DELIVER GAS FLOW TO THE PT AND THERE WERE NOT ANY AUDIBLE OR VISUAL ALARMS. VAPOTHERM IS NOT AWARE OF ANY INTERVENTION OR HARM TO THE PT. THE PRECISION FLOW UNIT POWERS A DISPOSABLE PT CIRCUIT (DPC) TO DELIVER HUMIDIFIED GAS TO A PT. VAPOTHERM FOUND THERE WAS A MISSING AIR INLET TUBE O-RING ON THE RETURNED DISPOSABLE WATER CIRCUIT (DWP). THEREFORE, GAS FLOW WILL LEAK OUT OF THE DWP INSTEAD OF PASSING THROUGH THE DWP. AN INSPECTION OF VAPOTHERM INVENTORY DID NOT DETECT ANY OTHER UNITS MISSING THE O-RING. THE INCIDENT IS THE RESULT OF AN ASSEMBLY ERROR. ALL DWPS ARE PRESSURE TESTED, BUT THE TEST APPARATUS IS BEING MODIFIED TO ENSURE REDUNDANT TESTING FOR A DWP WITHOUT AN O-RING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1