BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHTSTAR 330

    MDR report key: 1024316 · Received April 3, 2008

    Report

    Report Number
    8020893-2008-00154
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    GALWAY (RC)
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE INVESTIGATION CONFIRMED THAT THE UNIT STOPPED CYCLING DURING VENTILATION. THE DEVICE WAS REPAIRED, UPGRADED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    MANUFACTURE RECEIVED INFORMATION STATING THAT THE DEVICE STOPPED CYCLING DURING PATIENT USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIGHTSTAR 330 KNIGHTSTAR 330 CBK GALWAY (RC) KNIGHTSTAR 330

    Patients

    Seq Age Sex Outcome Treatment
    1