BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4221898 · Received November 3, 2014

    Report

    Report Number
    8020893-2014-02421
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CABLE, AND SOFTWARE WAS UPGRADED TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS. THE REPORTED ISSUE IS A KNOWN FAILURE. THREE SCENARIOS MAY OCCUR WHEN THE GRAPHICAL USER INTERFACE (GUI) DOES NOT FUNCTION AS INTENDED. (1) THE UPPER SCREEN BECOMES BLANK; (2) THE LOWER SCREEN BECOMES BLANK; (3) 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). (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR HAD AN ERRATIC LOWER DISPLAY WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701826 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention