BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4914838 · Received July 13, 2015

    Report

    Report Number
    2021710-2015-01185
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE EXAMINED THE UNIT AND DETERMINED THAT IT NEEDED A REPLACEMENT GAS DELIVERY ENGINE (GDE). A REPLACEMENT GAS DELIVERY ENGINE WAS SHIPPED TO THE CUSTOMER. A RETURN GOODS AUTHORIZATION (RGA) NUMBER WAS ALSO ISSUED FOR THE RETURN OF THE ALLEGED FAULTY GAS DELIVERY ENGINE FOR EVAL. AS OF JULY 9, 2015, CAREFUSION HAS NOT RECEIVED THE ALLEGED FAULTY GAS DELIVERY ENGINE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PROBLEM WITH INOP AND BLENDED GAS ALARMS. THIS IS THE THIRD TIME THAT THIS CUSTOMER HAS CALLED ABOUT THE SAME ISSUES ON THE SAME VENTILATOR. CAREFUSION TECHNICAL SUPPORT WAS NOT SURE IF THE UNIT WAS CALIBRATED PROPERLY AND/OR IF THE CABLES WERE SEATED CORRECTLY THE PREVIOUS TIMES. FIELD SERVICE WAS DISPATCHED TO EXAMINE THE UNIT. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452260 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA