BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E500 VENTILATOR

    MDR report key: 2842167 · Received November 15, 2012

    Report

    Report Number
    2023050-2012-00268
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 30, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, "SUSTAINED" AND "PAW LOW" ALARMS OCCURRED AND THE VENTILATOR STOPPED DELIVERING BREATHS. THE PT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER UNIT. IT WAS ALSO REPORTED THAT THERE WAS A "CONTROL UP FAILED" ERROR. THERE WERE NO REPORTED ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS E500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention