BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6676395 · Received June 29, 2017

    Report

    Report Number
    8020893-2017-06772
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PMA/510K TO K970460 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), THE BACKLIGHT INVERTER PCB¿S WERE UPGRADED AND THE LATEST VERSION OF THE OPERATIONAL SOFTWARE WAS INSTALLED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO MEDTRONIC¿S PRODUCT ANALYSIS LABORATORY. VISUAL INSPECTION OF THE RETURNED COMPONENT WAS CONDUCTED AND NO ANOMALIES WERE FOUND. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE IDENTIFIED ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO THE VIDEO GRAPHICS ARRAY (VGA) CONTROLLER ON THE GUI PCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458226 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1