BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4478064 · Received January 29, 2015

    Report

    Report Number
    2021710-2015-00170
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    December 30, 2014
    Report Date
    December 30, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAREFUSION CLINICAL MARKETING REPRESENTATIVE DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON THE INFORMATION DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A FROM A CAREFUSION CLINICAL MARKETING REPRESENTATIVE. (B)(4). THE ALLEGED FAULTY DEVICE WAS RECEIVED BY CAREFUSION ON JANUARY 13, 2015, ROUTED TO THE CAREFUSION SERVICE DEPARTMENT AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO AN EMAIL FROM A CAREFUSION CLINICAL MARKETING REPRESENTATIVE. "CLINICAL MARKETING DEMO UNIT IN FOR REPAIR THE UNIT CYCLES ON NORMAL BUT HAS AN UNRESPONSIVE TOUCHSCREEN DISPLAY TO TOUCH COMMANDS. THE UNIT WAS NOT IN ANY PATIENT DEMO USE DURING ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68387 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA CL10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA