BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 2033650 · Received February 11, 2011

    Report

    Report Number
    2124823-2011-00012
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 11, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED A LOSS OF TELEMETRY MONITORING FOR APPROXIMATELY 8 PATIENTS FOR MORE THAN ONE HOUR DUE TO A PRESUMED CLINICAL INFORMATION CENTER MOTHERBOARD FAILURE. THERE WAS NO REPORTED PATIENT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED 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