BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 3082617 · Received April 23, 2013

    Report

    Report Number
    2023050-2013-00328
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 4, 2013
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, PT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PT USE, AN 'O2 SENSOR DISCONNECT' ERROR OCCURRED. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173496 E360 VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360

    Patients

    Seq Age Sex Outcome Treatment
    1