BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM

    MDR report key: 8041347 · Received November 6, 2018

    Report

    Report Number
    8041347
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    May 6, 2018
    Report Date
    September 27, 2018
    Manufacturer
    VAPOTHERM, INC
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST (RT) WAS CALLED TO CHANGE INFANT FROM NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) TO HIGH FLOW NASAL CANNULA (HFNC). RT CAME TO CCN IMMEDIATELY AND BEGAN TO PLACE INFANT ON NASAL CANNULA. RN EXPLAINED THAT HIGH FLOW NEEDED TO BE GIVEN VIA THE VAPOTHERM. RT STATED THAT THE VAPOTHERM MACHINE NEVER WORKS AND RELUCTANTLY PLACED THE BABY ON HFNC VIA VAPOTHERM. CORRECT SETTINGS WERE PLACED (2L FLOW, 21% O2,RN QUESTIONED RT AS THE SCREEN ON THE VAPOTHERM WAS NOT STAYING LIT WITH THE SETTINGS. RT STATED THE SCREEN DOES NOT STAY LIT. RN CHECKED THE MANUAL WITH THE MACHINE AND CONFIRMED THAT THE YELLOW LIGHT MEANT NO FLOW WAS GOING TO THE PATIENT. RN PRESSED THE POWER BUTTON, THE GREEN LIGHT CAME ON AND SETTINGS WERE CONFIRMED. A FEW MINUTES LATER THE MACHINE BEGAN TO ALARM. RT WAS CALLED TO BEDSIDE AND CONFIRMED THAT THE ALARM SIGNALED THAT THE VAPOTHERM NEEDED TO BE SERVICED. RN CALLED NURSE PRACTITIONER AND PLACED INFANT ON NC 1L 21%. RT STATED THAT THEY DO NOT KEEP HUMIDIFICATION FOR NC ON THE FLOOR BUT THAT HE WOULD BRING IT UP ASAP. RT TOOK VAPOTHERM AND STATED THAT HE WOULD HAVE IT SERVICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881280 VAPOTHERM CANNULA, NASAL, OXYGEN CAT VAPOTHERM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA