BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3810737 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00682
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR P
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), BACKLIGHT INVERTER PCB'S AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST ACCORDING TO MFR SPECIFICATIONS. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATING THE GRAPHICAL USER INTERFACE (GUI) FOR AN 840 VENTILATOR EXPERIENCED AN ERRATIC DISPLAY. THERE WAS NO REPORT OF PT INVOLVEMENT AT THE TIME OF THE EVENT. THE DATE OF THE EVENT IS UNK. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169818 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR P 840

    Patients

    Seq Age Sex Outcome Treatment
    1