BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENT USA

    MDR report key: 3823399 · Received February 19, 2014

    Report

    Report Number
    8020893-2014-00405
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 21, 2014
    Manufacturer
    THE COVIDIEN TECHNICAL
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE TSE RECOMMENDED SWAPPING THE GRAPHIC USER INTERFACE (GUI) WITH A KNOWN GOOD UNIT TO VIEW THE DIAGNOSTIC CODES. THE CUSTOMER REPORTED TO HAVE REPLACED THE GUI CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THAT THE GUI CPU WAS REPLACED AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Description of Event or Problem · 1

    COVIDIEN REC'D INFO STATING THAT AN 840 VENTILATOR HAD LINES ACROSS THE DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104124 840 VENT USA CBK: VENTILATOR, CONTINUOUS, FACILITY CBK THE COVIDIEN TECHNICAL 840

    Patients

    Seq Age Sex Outcome Treatment
    1