BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHTSTAR 330

    MDR report key: 1031447 · Received April 18, 2008

    Report

    Report Number
    9615679-2008-00005
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 16, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REGISTRATION NUMBER IS INCORRECT USE BELOW NUMBER FOR REGISTRATION.

    Description of Event or Problem · 1

    MANUFACTURE RECEIVED INFO STATING THAT THE DEVICE STOPPED CYCLING DURING PT USE. DEVICE WAS USED IN AN HOSPITAL ENVIRONMENT. NO INJURY OR CHANGE IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIGHTSTAR 330 BI-LEVEL VENTILATOR CBK NELLCOR PURITAN BENNETT KNIGHTSTAR 330

    Patients

    Seq Age Sex Outcome Treatment
    1