BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1213816 · Received October 22, 2008

    Report

    Report Number
    8020893-2008-00550
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 15, 2008
    Manufacturer
    PURITAN-BENNETT IRELAND
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS 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 NELLCOR PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE SAFETY VALVE. THE UNIT PASSED EXTENDED SELF TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1