BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3922482 · Received June 2, 2014

    Report

    Report Number
    8020893-2014-01341
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT AND VERIFIED THE MALFUNCTION. THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCBS) WERE REPLACED, AND THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION. ALL REQUIRED CALIBRATIONS AND TESTS WERE PERFORMED, AND THE UNIT WAS OPERATING WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4). THE REPORTED ISSUE IS A KNOWN FAILURE. THREE SCENARIOS MAY OCCUR WHEN THE GUI DOES NOT FUNCTION AS INTENDED: THE UPPER SCREEN BECOMES BLANK; THE LOWER SCREEN BECOMES BLANK; THE UPPER AND LOWER SCREENS BECOME BLANK. COVIDIEN FAILURE INVESTIGATION HAS DETERMINED THAT THE ROOT CAUSE FOR THE 3 SCENARIOS DESCRIBED ABOVE IS THE FAILURE OF ONE OF THE DESIGNATOR COMPONENTS ON THE VIDEO GRAPHIC ARRAY (VGA) CONTROLLER LOCATED ON THE GUI PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR HAD BOTH DISPLAYS BLANK AND INOPERABLE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320949 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1