BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION FLOW

    MDR report key: 2003215 · Received February 21, 2011

    Report

    Report Number
    MW5019495
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    August 24, 2010
    Report Date
    February 21, 2011
    Manufacturer
    VAPOTHERM
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER RN, "PT DESATING INTO THE 70'S, RN TURNED FIO2 UP ON VAPOTHERM FROM 26 TO 28%. WITHIN 2 MINUTES OF OXYGEN CHANGE, VAPOTHERM MACHINE SPONTANEOUSLY TURNED OFF. RN ATTEMPTED TO TURN MACHINE BACK ON. MACHINE RESUMED SETTINGS AND A MINUTE LATER, MACHINE SPONTANEOUSLY TURNED OFF AGAIN. ONE HUNDRED PERCENT OXYGEN DELIVERED VIA AMBU BAG TO BRING SATS TO >90%. RT BROUGHT NEW VAPOTHERM EQUIPMENT. PT PLACED ON NEW EQUIPMENT AT 26%. PT RECOVERS TO O2 SATS >90% WITHIN 3 MINUTES. MALFUNCTIONING EQUIPMENT REMOVED FROM SERVICE. PT REMAINED ON NEW VAPOTHERM WITH NO DISTRESS." IN AN EFFORT TO RECREATE THE PROBLEM, THE REPORTED MALFUNCTIONING VAPOTHERM WAS RUN WITHOUT PROBLEM FOR 2 DAYS. THE COMPANY WAS CONTACTED BY THE DIRECTOR OF CARDIOPULMONARY AND BIOMEDICAL SERVICES. THE VAPOTHERM COMPANY SUGGESTED THAT THE BUTTON WAS PUSHED AFTER THE CHANGE AS AN "ENTER" BUTTON EXISTS ON MOST OTHER EQUIPMENT WE USE. THE PROBLEM WAS RE-CREATED. DIRECTOR OF CARDIOPULMONARY REQUESTS THAT THE BUTTON BE LABELED AS "RUN/STANDBY" TO PREVENT THIS EASILY MADE ERROR. NO CHANGES BY VAPOTHERM TO THE EQUIPMENT, AS PROMISED, AS OF(B)(6) 2011. THEREFORE, THIS REPORT IN AN ATTEMPT TO PREVENT FURTHER INCIDENCES. DIAGNOSIS OR REASON FOR USE: HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HEATED HIGH FLOW NASAL CANNULA BTT VAPOTHERM ALL ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability