BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1619857 · Received February 26, 2010

    Report

    Report Number
    2124823-2010-00011
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    September 3, 2009
    Report Date
    February 26, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXJ
    PMA / PMN Number
    K001112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE CENTRAL STATION (CIC) DID NOT PROVIDE AN ASYSTOLE ALARM FOR A PATIENT. THIS WAS THE ONLY ALARM/PATIENT REPORTEDLY AFFECTED. THE CUSTOMER WAS IN FRONT OF THE CENTRAL STATION AT THE TIME AND WITNESSED THE ARRHYTHMIA. NO PATIENT INJURY WAS REPORTED. A GE FIELD SERVICE ENGINEER (FSE) PERFORMED ARRHYTHMIA SIMULATIONS ON THE DEVICE AND DETECTED NO PROBLEMS. 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 CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DXJ GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1