BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 1945175 · Received November 30, 2010

    Report

    Report Number
    1945175
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 30, 2010
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    A CERTIFIED NURSING ASSISTANT ALERTED THE PULMONARY STAFF THAT THE VAPOTHERM UNIT WAS NOT FLOWING AND THE PATIENT'S O2 SATURATION WAS AT 47%. THE RESPIRATORY THERAPIST ON DUTY FOUND THAT THE DISPLAY ON THE VAPOTHERM UNIT WAS BLACK, NO FLOW WAS PRESENT AND NO ALARMS WERE ENGAGED. A NON-REBREATHER MASK WAS APPLIED UNTIL THE VAPOTHERM WAS REPLACED. THE DEFECTIVE VAPOTHERM WAS REMOVED FROM SERVICE PENDING AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HIGH FLOW HEAT AND HUMIDIFICATION DEVICE BTT VAPOTHERM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR