BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500 VENTILATION SYSTEM

    MDR report key: 2934937 · Received January 4, 2013

    Report

    Report Number
    2023050-2013-00016
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS
    Product Code
    CBK
    PMA / PMN Number
    K061094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING TESTING, DISTRIBUTOR FOUND THAT A NEWLY PURCHASED PANEL WAS NON FUNCTIONAL. THE TOUCH PANEL WAS NOT RESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5688 E500 VENTILATION SYSTEM CBK NEWPORT MEDICAL INSTRUMENTS E500

    Patients

    Seq Age Sex Outcome Treatment
    1