BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 2215125 · Received August 9, 2011

    Report

    Report Number
    2023050-2011-00037
    Event Type
    Other
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K052502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE RPTR DISPLAY ISSUE WAS SOLVED BY CHECKING THE EPROM ON THE DISPLAY BOARD. THEY VERIFIED THAT THE DISPLAY BOARD WAS SEATED PROPERLY BY REMOVING IT AND RESEATING IT AGAIN. TO DATE, THE VENTILATOR FUNCTIONS NORMALLY WITHOUT ANY FURTHER ISSUES. PLEASE NOTE THAT A VENTILATOR INDICATES "888" ON LED SEGMENTS WHEN THERE IS A MISCOMMUNICATION BETWEEN DISPLAY BOARD AND MAIN BOARD THAT ARE NOT CONTACTED PROPERLY.

    Description of Event or Problem · 1

    REPORTEDLY, ALL THE LED SEGMENTS DISPLAYED "888" WHILE THE PT WAS ON THE VENTILATOR. THE VENTILATOR KEPT VENTILATING THE PT; HOWEVER, IT WAS UNABLE TO CHANGE THE SETTING. THE PT WAS IMMEDIATELY TAKEN OFF FROM THE VENTILATOR, AMBU BAGGED, AND THEN SWITCHED TO A BACK-UP VENTILATOR PER DOCTOR'S ORDER. PLEASE NOTE THAT THERE WAS NO PERMANENT INJURY IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention