BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM 20001

    MDR report key: 964906 · Received November 3, 2006

    Report

    Report Number
    1125759-2006-00012
    Event Type
    Injury
    Date Received
    November 3, 2006
    Date of Event
    July 5, 2005
    Report Date
    November 3, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL'S NAME WAS NOT PROVIDED. NAMES OF PERSONS WHO MAY HAVE KNOWLEDGE OF THE EVENT WERE NOT PROVIDED. THEREFORE, AN INVESTIGATION INTO THE ALLEGED EVENT IS VERY DIFFICULT. VAPOTHERM EXERCISED DUE DILIGENCE BY TESTING SIMILAR DEVICES IN THE CO'S POSSESSION. THE CONCLUSION WAS THAT A THE DEVICE IS HIGHLY UNLIKELY TO CAUSE A THERMAL INJURY LIKE THE ONE REPORTED. CONCLUSION: UNDER INDUCED FAILURE CONDITIONS IN THE LOW FLOW RANGE, THE MAXIMUM TEMPERATURE WITHIN THE CANNULA NOSEPIECE CAN RISE ABOVE 44 DEGREES CELSIUS INTERMITTENTLY AT A FLOW OF 5 1PM. TEMPERATURES ABOVE 44 DEGREES CELSIUS ARE MAINTAINED FOR PERIODS OF APPROX 3 MINUTES, WITH LOWER TEMPERATURES MAINTAINED FOR APPROX 7 MINUTES AS THE THERMOSTAT OPENS AND CLOSES. HOWEVER, THE MAXIMUM POSSIBLE TEMPERATURE OF THE AIRFLOW REACHING MUCOSAL SURFACES IMMEDIATELY ADJACENT TO THE PRONG OUTLET IS APPROX 43-44 DEGREES CELSIUS FOR SHORT PERIODS. TEMPERATURE DECLINES RAPIDLY WITH DISTANCE FROM THE OUTLET, SO THAT POTENTIAL EXPOSURE OF THE NASAL MUCOSA TO TEMPERATURES ABOVE 40 DEGREES CELSIUS IS LIMITED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM FDA AT VAPOTHERM ON 10/3/06. THE EVENT WAS DESCRIBED BY FDA ON 8/15/06. EVENT NOTIFICATION TO FDA BY USER IS 9/15/05 AND DATE OF THE EVENT IS 7/15/05. THE DESCRIPTION IS: "INFANT PLACED ON VAPOTHERM UNIT ABOUT 6 HOURS AFTER BIRTH. AT 24 HURS OF AGE, RIGHT CHEEK AND NARES NOTED TO BE RED AND BLISTERED AND OOZING YELLOW FLUID. A 2.5 CM X 6 TO 8 MM BLISTER ON RIGHT CHEEK AND RAW RED AND OOZING NASAL TURBINATE WITH NEAR OCCLUSION OF NARES BY 60 HRS. THERE WAS NO HIGH TEMP ALARM NOTED." NO HOSP IS NAMED. NO INDIVIDUAL IS NAMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM 20001 BTT BTT VAPOTHERM, INC. 20000I UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention