BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4092676 · Received August 19, 2014

    Report

    Report Number
    8020893-2014-02076
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 11, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE TELEPHONE. THE CUSTOMER REPORTED TO HAVE RUN THE DEVICE ON A TEST LUNG, AS RECOMMENDED BY THE TSE, AND WAS UNABLE TO DUPLICATE THE ALLEGED MALFUNCTION. NO PARTS WERE REPLACED. THE CUSTOMER REPORTED THAT THE DEVICE 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, THE 840 VENTILATOR GRAPHIC USER INTERFACE (GUI) WAS INOPERABLE, AND ERROR CODES WERE RECORDED IN THE MEMORY LOGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496872 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1