BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    680 PROVIDER SYSTEM

    MDR report key: 817263 · Received February 6, 2007

    Report

    Report Number
    817263
    Event Type
    Malfunction
    Date Received
    February 6, 2007
    Date of Event
    February 5, 2007
    Report Date
    February 6, 2007
    Manufacturer
    JERON ELECTRONIC SYSTEMS, INC.
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    WE HAVE THE JERON PROVIDER 680 NURSE CALL SYSTEM IN OUR NICU WITH OUR PHONE SYSTEM. MONITORS ARE HOOKED UP INTO THE NURSE CALL SYSTEM TO NOTIFY THE NURSES WHEN IT ALARMS. THE PHONE SYSTEM CONTINUALLY GETS LOCKED UP IN THE NURSE CALL SYSTEM. A BABY WENT INTO A BRADY ALARM AND THE NURSE WAS NOT NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 680 PROVIDER SYSTEM NURSE CALL SYSTEM ILQ JERON ELECTRONIC SYSTEMS, INC. PROVIDER 680 SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *