BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1030937 · Received April 17, 2008

    Report

    Report Number
    2124823-2008-00046
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 17, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K032370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF AUDIBLE ALARMS OCCURRED AT THE CIC. IT IS UNK AT THIS TIME WHETHER THE CIC WAS SUPPORTING BEDSIDE OR TELEMETRY PTS. NO PT INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1