BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3980799 · Received July 24, 2014

    Report

    Report Number
    8020893-2014-01790
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE, AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE LOWER LIQUID CRYSTAL DISPLAY (LCD) PANEL. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MFG SPECS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, AN 840 VENTILATOR HAD AN ERRATIC LOWER DISPLAY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435584 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1