BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE HUMIDIFIER KIT 500ML

    MDR report key: 5619262 · Received April 29, 2016

    Report

    Report Number
    5619262
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 19, 2016
    Manufacturer
    CAREFUSION 211, INC. DBA AS CAREFUSION
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRE-FILLED HUMIDIFIER STERILE WATER FOR INHALATION 500ML WITH HUMIDIFIER ADAPTOR PROBLEMS: ADAPTOR FAILED TO CONNECT/SCREW INTO THE AIR FLOW METER CORRECTLY AFTER REPEATED ATTEMPTS (THIS HAS HAPPENED REPEATEDLY THROUGHOUT PAST MONTHS) AND WHEN TOP ROUND SECTION STEM IS BROKEN OFF TO ALLOW BOTTOM PART OF THE ADAPTOR TO SCREW IN, IT IS VERY DIFFICULT AND AT TIMES UNABLE TO SCREW IN AT ALL. WE HAVE HAD TROUBLE WITH A BABY MAINTAINING OXYGEN SATURATIONS WHEN USING THIS DEVICE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274031 AIRLIFE HUMIDIFIER KIT 500ML HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT CAREFUSION 211, INC. DBA AS CAREFUSION 002620 TL1214001

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other JUST THE AIR FLOW METERS THAT THE ADAPTOR WAS SUPP