BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHTSTAR 330

    MDR report key: 1001216 · Received February 22, 2008

    Report

    Report Number
    8020893-2008-00035
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CONFIRMED THAT DEVICE WILL NOT BE RETURNED; CUSTOMER DECLINES FAILURE INVESTIGATION AND SVC OF THE DEVICE.

    Description of Event or Problem · 1

    NPB RECEIVED INFO WHICH SUGGESTS THAT A KNIGHTSTAR 330 STOPPED VENTILATING WHILE IN PT USE. NO PT HARM. BIOMED STAFF WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK