BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3853465 · Received April 4, 2014

    Report

    Report Number
    8020893-2014-00814
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    COVIDIEN FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE FOUND THE LIQUID CRYSTAL DISPLAY (LCD) FLEX CABLE WAS BROKEN. THE LCD FLEX CABLE WAS REPLACED AND THE UNIT THEN PASSED ALL TESTING.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4). DURING THE REPAIR OF THIS DEVICE THE CUSTOMER SUPPORT ENGINEER (CSE)REPLACED BOTH THE GRAPHIC USER INTERFACE (GUI) FLEX CABLE AND THE GUI PRINTED CIRCUIT BOARD (PCB). THE GUI PCB WAS RETURNED FOR INVESTIGATION. THE RETURNED DEVICE WAS INVESTIGATED AND FOUND TO BE THE ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD ERRATIC GRAPHICAL USER INTERFACE (GUI). THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203569 840 VENTILATOR CBK, VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1