BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHTSTAR

    MDR report key: 1203420 · Received October 15, 2008

    Report

    Report Number
    8020893-2008-00534
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFORMATION STATING DEVICE STOP CYCLING DURING PATIENT USE. NO PATIENT INJURY REPORTED AND NO CHANGE IN MEDICAL TREATMENT DUE TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1