BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHTSTAR 330

    MDR report key: 1133444 · Received August 22, 2008

    Report

    Report Number
    8020893-2008-00378
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 25, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFORMATION STATING THAT BLACK DUST WAS OBSERVED IN PATIENT TUBING. NO PATIENT 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