BEUDAMED
    FDA Adverse Event Other Summary report: N

    E500

    MDR report key: 1702006 · Received May 12, 2010

    Report

    Report Number
    1702006
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 12, 2010
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE VENTILATORS REMOTE ALARM TO THE NURSE CALL SYSTEM(SIMPLEX-GRINNELL. EZ-CARE NURSE CALL)STAYS LOCKED AND WILL NOT CLEAR THE NURSE CALL ALARM, EVEN THOUGH THE VENT IS FUNCTIONAL AND NOT CAUSING AN ALARM EVENT.====================== MANUFACTURER RESPONSE FOR VENTILATOR, E-500======================THIS IS AN ONGOING PROBLEM WE HAVE WITH THE VENTS FOR THE PAST 2 YEARS AND HAVE LET NEWPORT KNOW AND HAS NOT BEEN RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1