BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE NCPAP

    MDR report key: 2082624 · Received April 28, 2011

    Report

    Report Number
    2082624
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 28, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    FISHER PAYKEL HUMIDIFIER CHAMBER WAS OVERFILLED BY RESPIRATORY THERAPIST (RT). WATER FROM CHAMBER WENT INTO THE PATIENT CIRCUIT AND TO THE PATIENT. PT HAD A BRADYCARDIC EPISODE AND WAS UNRESPONSIVE TO TACTILE STIMULATION. ADMINISTERED POSITIVE PRESSURE VENTILATION (PPV) VIA NEO PUFF (AMBU BAG) AND PT RESPONDED TO PPV VIA AMBU BAG AND MASK. CIRCUIT WAS DRAINED AND HUMIDIFIER CHAMBER WAS DRAINED TO SAFE LEVEL. PT WAS PLACED BACK ON NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP). FRACTION OF INSPIRED OXYGEN (FIO2) DECREASED TO PRIOR LEVEL. COINCIDING WITH THIS, PLEURAL FLUID DRAINED VIA IN-PLACE IV CATHETER (32 CC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE NCPAP VENTILATOR, HUMIDIFIER BZD CAREFUSION 006900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO