BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1213814 · Received October 22, 2008

    Report

    Report Number
    8020893-2008-00549
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PURITAN BENNETT WAS NOT AUTHORIZED TO SERVICE THIS VENTILATOR. THE CUSTOMER REPLACED THE BDU CPU BOARD. IT WAS REPORTED VENT PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE INVESTIGATION AND SERVICE WERE REPORTED TO BE COMPLETED BY THE CUSTOMER. CUSTOMER REPLACED THE BDU. CSE PERFORMED SOFTWARE UPGRADE ONLY. THE DEVICE PASSED ALL FUNCTIONAL TESTS REQUIRED FOR THIS PRODUCT. THE SERVICE HISTORY RECORDS FOR THIS VENTILATORS SERIAL NUMBER WERE INVESTIGATED. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND FAILURE TRENDS WILL CONTINUE TO BE MONITORED.

    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