BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 4115769 · Received September 24, 2014

    Report

    Report Number
    8020893-2014-02227
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN RECEIVED THE BREATH DELIVERY PRINTED CIRCUIT BOARD (BD PCB) REPORTED TO HAVE EXHIBITED A LOSS OF COMMUNICATION ERROR CODE. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED COMPONENT, NO ANOMALIES WERE OBSERVED. FUNCTIONALITY TESTS AND CALIBRATION WERE PERFORMED AS DETAILED IN THE 840 VENTILATOR SERVICE MANUAL. FAILURE INVESTIGATION TEST VENTILATOR WAS USED TO RUNNING THE TESTS, AND THE BD PCB WAS ATTACHED TO IT FOR ANALYSIS. THE VENTILATOR WAS POWERED UP WITHOUT ISSUES, TESTED AND CALIBRATED, AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. UPON PLACING THE VENTILATOR INTO VENTILATION MODE, IT GENERATED A GUI INOP CONDITION, AND ERROR CODES WERE RECORDED IN THE DIAGNOSTIC LOGS. THE FAULT WAS ISOLATED TO COMPONENT U6, A COAXIAL TRANSCEIVER INTERFACE DEVICE. U6 IS A SIGNIFICANT COMPONENT IN THE ETHERNET COMMUNICATIONS CIRCUITRY LINKING THE BD AND GRAPHICAL USER INTERFACE (GUI) CPU BOARDS. COMPONENT U6 WAS REPLACED. THE BD PCB WAS AGAIN ATTACHED TO THE FAILURE INVESTIGATION TEST VENTILATOR, TESTED AND CALIBRATED, AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. DURING THE 24 HOURS TESTS ON VENTILATION MODE, NO ERRORS WERE OBSERVED. THE REPORTED FAILURE WAS VERIFIED.

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB), AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION TO RESOLVE THE ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, THE 840 VENTILATOR GRAPHICAL USER INTERFACE (GUI) EXHIBITED ¿LOSS OF COMMUNICATION¿ ERROR CODE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594566 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention