BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G.E. MEDICAL SYSTEMS

    MDR report key: 1623579 · Received March 3, 2010

    Report

    Report Number
    MW5014993
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 23, 2010
    Report Date
    February 26, 2010
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    G.E. DASH 5000 PHYSIOLOGIC MONITOR LOST ECG TRACING ON STABLE POST-OPERATIVE PATIENT WHO HAD BEEN IN A NORMAL SINUS RHYTHM. "LEAD FAIL" MESSAGE REGISTERED ON SCREEN. ALL LEADS WERE ATTACHED TO PATIENT SECURELY. APPARENT HISTORIC 2-3 YEARS LONG PROBLEM OF "LEADS FAIL" MESSAGE WITH CORRESPONDENT LOSS OF ECG TRACING HAS BEEN DEALT WITH MANUFACTURER'S REP WITHOUT SUCCESSFUL RESOLUTION TO DATE. ONE OF THESE 10 MONITORS WAS EVEN TAKEN TO BE BENCH-TESTED AT G.E. MEDICAL; WHERE IT WAS DETERMINED TO PERFORM NOMINALLY. THIS APPEARS TO BE AN INTERMITTENT PROBLEM THAT 13 UNPREDICTABLE. THE NURSES AND TECHS USING THIS EQUIPMENT HAVE ALL BEEN PROPERLY IN-SERVICED IN USE OF THESE MONITORS. THIS HOSPITAL IS FILLED WITH SIMILAR (ALTHOUGH NOT SAME) MONITORS - AND WE HAVE NOT HEARD OF SIMILAR REPORTS OF PROBLEMS AS WE HAVE WITH THESE DASH 5000 SERIES MONITORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    10 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    2 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    3 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    4 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    5 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    6 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    7 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    8 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000
    9 G.E. MEDICAL SYSTEMS DASH 5000 PHYSIOLOGIC MONITOR MHX DASH 5000

    Patients

    Seq Age Sex Outcome Treatment
    1