BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3964635 · Received May 30, 2014

    Report

    Report Number
    8020893-2014-01313
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE VENTILATOR AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE LIQUID CRYSTAL DISPLAY (LCD) PANEL TO RESOLVE THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4). THE REPORTED ISSUE IS A KNOWN FAILURE. THREE SCENARIOS MAY OCCUR WHEN THE GUI DOES NOT FUNCTION AS INTENDED. THE UPPER SCREEN BECOMES BLANK;. THE LOWER SCREEN BECOMES BLANK; THE UPPER AND LOWER SCREEN BECOME BLANK. COVIDIEN FAILURE INVESTIGATION HAS DETERMINED THAT THE ROOT CAUSE FOR THE 3 SCENARIOS DESCRIBED ABOVE IS THE FAILURE OF ONE OF THE DESIGNATOR COMPONENTS ON THE VIDEO GRAPHIC ARRAY (VGA) CONTROLLER LOCATED ON THE GUI PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A BLANK LOWER DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319996 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1