BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1203343 · Received October 15, 2008

    Report

    Report Number
    8020893-2008-00535
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NPB WAS NOT AUTHORIZED TO SERVICE THIS DEVICE. THE CUSTOMER REPORTED TO HAVE REPLACED THE BDU CPU BOARD. IT WAS REPORTED VENT PASSED ALL TESTING.

    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