BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1111837 · Received August 13, 2008

    Report

    Report Number
    8020893-2008-00407
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 6, 2008
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE NELLCOR PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE, AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF-TESTING.

    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