BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 2120930 · Received May 31, 2011

    Report

    Report Number
    2120930
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CAREFUSION 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE VENTILATING PATIENT, THE INFANT VENTILATOR BEGAN AUTO TRIGGERING GIVING THE PATIENT UNNECESSARY ADDITIONAL BREATHS. THE CLINICIAN EXCHANGED THE NEONATAL FLOW TRANSDUCER, CALIBRATED, AND RE-TESTED. THE VENTILATOR RESUMED NORMAL RESPONSE TRIGGERING. THERE HAVE BEEN SEVERAL REPORTS AND OCCURRENCES OF THIS AUTO TRIGGER FAILURE. THE THERAPIST INSPECTED THE TRANSDUCER AND NOTED "BURNING" AND DISCOLORATION OF THE TRANSDUCER CONNECTOR ASSEMBLY. SENSOR SENT TO BIOMEDICAL WHERE THE DISCOLORATION WAS CONFIRMED AS AN OVERHEATED PIN. ADDITIONAL INSPECTION OF SEVERAL OTHER TRANSDUCERS NOTED BURNT AND DAMAGED PINS. BIOMEDICAL RETRIEVED 4 SENSORS TO BE SENT TO MANUFACTURER FOR ANALYSIS.======================MANUFACTURER RESPONSE FOR VENTILATOR, INFANT/NEONATAL, AVEA (PER SITE REPORTER)======================WILL ARRANGE TO RETURN FLOW SENSORS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 207, INC. AVEA *
    2 AVEA VENTILATOR, SENSOR, FLOW CBK CAREFUSION 207, INC. 16465 *
    3 AVEA VENTILATOR, SENSOR, FLOW CBK CAREFUSION 207, INC. 16465 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *