BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2432861 · Received January 11, 2012

    Report

    Report Number
    2124823-2012-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL INFO CENTER (CIC) WENT DOWN AND NO BACK UP CIC WAS AVAILABLE ON THE UNIT. THE HOSP STATED THIS WAS NOTICED IMMEDIATELY, HOWEVER, THE FAILURE WAS UNEXPECTED. A TOTAL OF 24 TELEMETRY PTS WERE WITHOUT TELEMETRY MONITORING FOR 30 MINUTES. THE EVENT DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U 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 DXJ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1