BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3983183 · Received July 3, 2014

    Report

    Report Number
    8020893-2014-01557
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPORTED THAT THE CUSTOMER DECIDED NOT TO HAVE THE DEVICE REPAIRED, AND INSTEAD, RETIRE THE 12 YEAR-OLD VENTILATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR EXPERIENCED A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) TO BREATH DELIVERY UNIT (BDU). THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392423 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1