BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC

    MDR report key: 2081136 · Received April 14, 2011

    Report

    Report Number
    2124823-2011-00042
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K032370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY MONITORING WAS LOST ON FOUR PATIENTS FOR SEVERAL MINUTES. TWO CENTRAL STATIONS AND TWO MIRROR STATIONS WERE AFFECTED. THE LOSS OF MONITORING WAS IMMEDIATELY DETECTED AND THERE WAS NO REPORTED PATIENT INCIDENT. 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 CIC CENTRAL STATION DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1