BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1831909 · Received September 8, 2010

    Report

    Report Number
    8020893-2010-00454
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PURITAN BENNETT CORP
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SUPPORT TROUBLESHOOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO RUN TEST AND ON TEST LUNG FOR 24 HOURS.

    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. CUSTOMER REPORTED TO HAVE NOT DUPLICATED THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK PURITAN BENNETT CORP 840

    Patients

    Seq Age Sex Outcome Treatment
    1