BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4808075 · Received May 29, 2015

    Report

    Report Number
    2021710-2015-01061
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A CAREFUSION FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE USER FACILITY. THE FIELD SERVICE REPRESENTATIVE EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE/VERIFY THE REPORTED EVENT. THE CAREFUSION FIELD SERVICE REPRESENTATIVE RAN THE DEVICE THROUGH THE OPERATIONAL VERIFICATION PROCEDURE (OVP) AND THE DEVICE PASSED ALL TESTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION HAS DISPATCHED A CAREFUSION FIELD SERVICE REPRESENTATIVE TO EVALUATE AND REPAIR THE DEVICE. THE CAREFUSION FIELD SERVICE REPRESENTATIVE HAS NOT COMPLETED THE EVALUATION OF THE DEVICE AS MAY 27, 2015. CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT ONCE THE EVALUATION AND REPAIR HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY BIOMED REPORTED THAT WHEN DOING THE COMPRESSOR TEST AND THE DEVICE IS SWITCHED FROM WALL AIR TO COMPRESSOR THEY GET COMPRESSOR OUTPUT LOW ERROR ("LOSS, AIR" MESSAGE) ON THE SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350378 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA