BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCHATERM NEPTUNE HEATED HUMIDIFIER

    MDR report key: 4726797 · Received April 24, 2015

    Report

    Report Number
    4726797
    Event Type
    Death
    Date Received
    April 24, 2015
    Date of Event
    February 6, 2015
    Report Date
    March 13, 2015
    Manufacturer
    TELEFLEX MEDICAL INC
    Product Code
    BTT
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENTILATOR SET UP ON (B)(6) 2015 FOR GESTATION (B)(6) INFANT WHO WAS BORN IN THE CAR WITH TWIN ENROUTE TO THE HOSPITAL. ON (B)(6) 205 BABY STARTED TO EXHIBIT SOME RESPIRATORY DISTRESS. BABY REINTUBATED MUCUS FOUND ON END OF TUBE. AFTER INTUBATION ATTEMPTED SUCTION OF BABY AND RED BLOOD NOTED. BABY DIED. ULTRASOUND OF HEAD ALSO NOTED BILATERAL GERMINAL MATRIX HEMORRHAGES. UPON CLEANING UP OF EQUIPMENT RT NOTICED WATER BOTTLE FOR ACTIVE HUMIDITY CIRCUIT WAS NOT SPIKE CAUSING THE EDEMA TO BE DRY. THEREFORE NO HUMIDITY SPIKE HAD GONE IN BUT NOT PUNCTURE ONE AND WATER BOTTLE. TEMPERATURE ALARM DID NOT SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273111 CONCHATERM NEPTUNE HEATED HUMIDIFIER HUMIDIFIER SYSTEM BTT TELEFLEX MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death