BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM

    MDR report key: 746594 · Received September 21, 2005

    Report

    Report Number
    MW1036686
    Event Type
    Injury
    Date Received
    September 21, 2005
    Date of Event
    August 31, 2005
    Report Date
    September 21, 2005
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 26 WEEK GESTATION PRETERM INFANT WHO HAD BEEN ON A CONVENTIONAL VENTILATOR -SERVO 300- FROM BIRTH FOR RESPIRATORY DISTRESS SYNDROME. IMPROVED TO POINT OF EXTUBATION AND PLACED ON VAPTHERM UNIT. STABLE FOR SEVERAL DAYS THEN DEVELOPED WORSENING RESPIRATORY STATUS REQUIRING REINTBUATION 7 DAYS LATER. A TRACHEAL ASPIRATE OBTAINED THE FOLLOWING DAY GREW RALSTONIA MANNITOLILYTICA WHICH WAS INITIALLY IDENTIFIED AS BURKHOLDERIA CEPACIA. THE INFANT RECEIVED A 14 DAY COURSE OF CIPROFLOXACIN AND CEFOTAXIME. SHE IMPROVED AND WAS EXTUBATED TO NASAL CPAP EIGHT DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM HIGH FLOW NASAL CANNULA BTT VAPOTHERM, INC. 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DAY Required Intervention