BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3940427 · Received June 18, 2014

    Report

    Report Number
    8020893-2014-01434
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCBS), THE SOFTWARE WAS UPGRADED TO THE CURRENT REVISION. THE UNIT THEN PASSED ALL TESTING AND OPERATES WITHIN THE MFG SPECIFICATIONS. (B)(4). THE REPORTED ISSUE IS A KNOWN FAILURE. THREE SCENARIOS MAY OCCUR WHEN THE GRAPHICAL USER INTERFACE (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 THREE 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

    A REPORT RECEIVED FROM (B)(6) STATED AN 840 VENTILATOR EXPERIENCED A BLANK DISPLAY WHILE BEING USED ON A PT. THE PT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357767 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention