BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2102223 · Received May 19, 2011

    Report

    Report Number
    2124823-2011-00073
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K032370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS BEING REPORTED THAT A NEC TELEMETRY TRANSMITTER(S) BEING USED ON A CLINICAL INFORMATION CENTER (CIC) FAILED TO PRODUCE AN ECG LEADS FAIL MESSAGE, YELLOW ALERT BOX, OR AUDIBLE ALARM WHEN THE TRANSMITTER WAS IN A LEADS FAIL CONDITION. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER CENTRAL STATION DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1