BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIGHTSTAR 330

    MDR report key: 2801255 · Received October 17, 2012

    Report

    Report Number
    8020893-2012-00959
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GALWAY (RC) - RX
    Product Code
    MNT
    PMA / PMN Number
    K003075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COVIDIEN - (B)(4) PROVIDED INFO STATING DEVICE STOP CYCLING DURING PT USE. NO PT INJURY OR DEATH REPORTED AND NO MEDICAL TREATMENT DUE TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIGHTSTAR 330 BI-LEVEL VENTILATOR MNT GALWAY (RC) - RX KNIGHTSTAR 330

    Patients

    Seq Age Sex Outcome Treatment
    1