BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2121856 · Received May 20, 2011

    Report

    Report Number
    8020893-2011-00242
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF-TESTING AND NO PARTS WERE REPLACED. IT IS NOT VERIFIED THAT THE VENT WAS INOPERABLE, AND THAT A MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1