BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 2081151 · Received April 14, 2011

    Report

    Report Number
    2124823-2011-00043
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED A SYSTEM WIDE LOSS OF TELEMETRY MONITORING FOR 400 BEDS FOR APPROXIMATELY 30 MINUTES DUE TO A PRESUMED SYNCHRONIZATION MASTER HARDWARE FAILURE. A MANUAL PROCESS WAS REQUIRED TO RESTORE TELEMETRY. NO ALTERNATE MONITORING WAS ESTABLISHED DURING THIS TIME. THERE WERE NO PATIENT INJURIES REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIC PRO CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1