BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 4009392 · Received July 11, 2014

    Report

    Report Number
    2021710-2014-00038
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE FOREIGN USER FACILITY NOR THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. (B)(4). CAREFUSION IS IN THE PROCESS OF COORDINATING WITH THE USER FACILITY AND THE DISTRIBUTOR IN (B)(4) FOR THE RETURN OF THE ALLEGED FAULTY DEVICE TO THE CAREFUSION FAILURE ANALYSIS LAB FOR EVALUATION. ONCE THE ALLEGED FAULTY DEVICE HAS BEEN RECEIVED, EVALUATED BY THE CAREFUSION FAILURE ANALYSIS LAB AND CAREFUSION HAS COMPLETED OUR INVESTIGATION, WE WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION CONCERNING THE REPORTED EVENT WAS COPIED FROM A CAREFUSION VENTILATION COMPLAINT FORM THAT WAS SUBMITTED TO CAREFUSION BY THE DISTRIBUTOR IN (B)(4). "AT 23:58, UNIT TURNS OFF WITHOUT ANY AUDIBLE ALARM OR FAULT MESSAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406944 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1