BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION FLOW VAPOTHERM

    MDR report key: 1303306 · Received February 2, 2009

    Report

    Report Number
    MW5009819
    Event Type
    Injury
    Date Received
    February 2, 2009
    Date of Event
    January 29, 2009
    Report Date
    February 2, 2009
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE: HIGH FLOW NASAL CANULA - HFNC - BY PRECISION FLOW VAPOTHERM INJURY: INFANT HAD APNEA AND BRADYCARDIA THAT REQUIRED AMBU BREATHS DUE TO WATER BEING INDUCED UP THE NARES BY THE HFNC. EVENT SEQUENCE: WATER BAG WAS NOTED TO BE HYPERINFLATED WITH AIR AT 0721 WITH ROUTINE CHECK, BAG WAS CHANGED OUT AND ALL OTHER SETTINGS WERE PERFORMING APPROPRIATELY. AT 0755 NEONATOLOGIST ATTEMPTED TO DECREASE THE FLOW TO 41/M BUT THE MACHINE WOULD NOT ALLOW THE CHANGE AND HE CALLED RESP. THERAPIST TO BEDSIDE. ASSESSMENT WAS MADE AND MACHINE WAS TURNED OFF, BUT THE CANNULA WAS LEFT IN THE NARES WHILE RT WENT TO RETRIEVE ANOTHER MACHINE. UPON RETURN RT NOTED THAT NURSE AT BEDSIDE, INFANT APPEARED TO BE CHOKING AND NURSE WAS HAVING TO RESUSCITATE INFANT WITH BLOW BY OXYGEN VIA AMBU BAG. IT APPEARED THAT WATER WAS BEING FORCED UP THE NARES VIA THE CANNULA THAT WAS ATTACHED TO THE HFNC WHICH WAS IN THE OFF MODE. NEONATOLOGIST AT BEDSIDE ALSO, HR AND SATS DOWN, INFANT REQUIRED IPPV BREATHS WITH AMBU TO REVIVE. SECOND MACHINE WAS PLACED AND BABY WAS NOTED TO BE RESTING COMFORTABLE WITH GOOD HEART RATE AND SATS WITH FLOW AT 41/M AND FIO AT 25%. DIAGNOSIS OR REASON FOR USE: PULMONARY ISSUES IN PREMATURE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW VAPOTHERM HIGH FLOW NASAL CANNULA SYSTEM CAT VAPOTHERM, INC. SN-PF-00001290-P

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Disability