BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 1800096 · Received August 10, 2010

    Report

    Report Number
    8020893-2010-00399
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    June 19, 2010
    Report Date
    July 29, 2010
    Manufacturer
    PURITAN BENNETT CORP
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACED INSPIRATORY MODULE AND WATER TRAP KIT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WATER LINES ACCIDENTLY BROKE CAUSING THE VENTILATOR TO STOP CYCLING WHILE IN PT USE. THE PT 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