BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4170107 · Received October 14, 2014

    Report

    Report Number
    8020893-2014-02338
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE PROPORTIONAL SOLENOID VALVE ASSEMBLY (PSOL). THE CSE PERFORMED ALL CALIBRATIONS, AND PERFORAMNCE VERIFICATION TESTS. THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SOLENOID (PSOL) VALVE WAS RECEIVED FOR AN INVESTIGATION. IT WAS INSTALLED INTO A FAILURE INVESTIGATION (FI) TEST VENTILATOR FOR ANALYSIS, AND ALL TESTS AND CALIBRATIONS WERE PERFORMED, AND NO ERRORS WERE OBSERVED. THE FI VENTILATOR WAS PUT INTO VENTILATION MODE FOR A MINIMUM OF 24 HOURS USING DEFAULT SETTINGS AS PER 840 SERVICE MANUAL. NO FAILURES OCCURRED. THE REPORTED MALFUNCTION WAS NOT VERIFIED, AS THE RETURNED COMPONENT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, THE 840 VENTILATOR STOPPED CYCLING. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648920 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1