BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4121880 · Received September 26, 2014

    Report

    Report Number
    8020893-2014-02259
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE PERFORMED THE 9.4 BACKLIGHT FIELD ACTION, INCLUDING THE CABLE ASSEMBLY, WHICH RESOLVED THE ISSUE. NO OTHER COMPONENTS WERE REPLACED OR REPAIRED. THE UNIT PASSED ALL TESTS AND CALIBRATIONS PER THE SERVICE MANUAL, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A 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 AND UPGRADED GRADED THE SOFTWARE TO THE CURRENT LEVEL. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST (SST), EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TESTING ACCORDING TO MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT BOTH THE UPPER AND LOWER DISPLAYS ON THE 840 VENTILATOR WERE BLANK. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600620 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1