BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2181060 · Received July 7, 2011

    Report

    Report Number
    2124823-2011-00109
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 7, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K001112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY MONITORING WAS LOST ON APPROXIMATELY 10 PATIENTS FOR 4-6 HOURS. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT, NOR WAS MEDICAL INTERVENTION REQUIRED. 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 CLINICAL INFORMATION CENTER CENTRAL STATION DXJ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1