BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3201989 · Received June 27, 2013

    Report

    Report Number
    8020893-2013-01409
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 30, 2013
    Manufacturer
    COVIDIEN, FORMELRY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING. THERE WAS NO PT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE BREATH DELIVERY UNIT (BDU) PCB. COVIDIEN LOADED THE SOFTWARE ONLY AND CONDUCTED THE FINAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293039 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMELRY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1