BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1242873 · Received November 19, 2008

    Report

    Report Number
    8020893-2008-00610
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 13, 2008
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION OF THIS VENTILATOR IS COMPLETE.

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    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