BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3193200 · Received June 25, 2013

    Report

    Report Number
    8020893-2013-01391
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD A BLANK DISPLAY. NO PT INVOLVEMENT REPORTED. EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. ONCE COMPLETED A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289019 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1