BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4914835 · Received July 13, 2015

    Report

    Report Number
    2021710-2015-01190
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 11, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAREFUSION FAILURE ANALYSIS TECHNICIAN EXAMINED THE MAIN PCBA COLDFIRE AND FOUND THAT ON CONNECTOR JP1, PIN 13 IS BENT. THIS CAUSED THE CABLE TO NOT CONNECT PROPERLY. THIS CABLE TRANSFERS THE TURBINE INFORMATION. STRAIGHTENED THIS PIN, CONNECTED CABLE AND NOW THE UNIT¿S TURBINE SERIAL NUMBER IS VALID. PCBA WAS INSTALLED INTO A KNOWN GOOD VELA TEST VENT AND THE VENT NOW FUNCTIONS NORMALLY. DUPLICATED, TURBINE SERIAL NUMBER BECAME INVALID, COMPLAINT ALLEGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOREIGN DISTRIBUTOR EVALUATED THE DEVICE AND DETERMINED THAT THE REPORTED EVENT WAS CAUSED BY A MALFUNCTIONING MAIN BOARD. THE FOREIGN DISTRIBUTOR WAS SHIPPED A REPLACEMENT MAIN BOARD KIT TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY MAIN BOARD FOR EVAL. AS OF JULY 9, 2015 THE ALLEGED FAULTY MAIN BOARD HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE FOREIGN DISTRIBUTOR IN (B)(6) REPORTED THAT DURING A REGULAR INSPECTION, "MOTOR FAILURE" ALARM OCCURRED AND THE VENTILATOR STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452259 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA