BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3964622 · Received May 30, 2014

    Report

    Report Number
    8020893-2014-01318
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THE 840 VENTILATOR REPORTED ISSUE WITH THE CUSTOMER OVER THE TELEPHONE. THE USER FACILITY WAS ADVISED TO PERFORM GROUND ISOLATION, REPLACE THE GRAPHIC USER INTERFACE (GUI) CABLE, AND RUN AN EXTENDED SELF-TEST. NO ADDITIONAL INFORMATION WAS PROVIDED TO THE MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR WAS DISPLAYING ERROR CODES INDICATING LOSS OF GRAPHIC USER INTERFACE (GUI) COMMUNICATION, AND WAS SHUTTING DOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320055 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1