BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIVIEW WORKSTATION

    MDR report key: 976013 · Received January 7, 2008

    Report

    Report Number
    1220063-2008-00048
    Event Type
    Malfunction
    Date Received
    January 7, 2008
    Date of Event
    December 4, 2007
    Report Date
    January 7, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC LOGS AND SCREEN SHOTS FROM THE DEVICE WERE RECEIVED FOR ANALYSIS. THIS ANALYSIS IS CURRENTLY IN PROCESS. RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFO FROM A CUSTOMER THAT OUR MULTIVIEW WORKSTATION DISPLAY EXPERIENCED A LOSS OF WAVEFORM AND PARAMETER DISPLAY FOR A TELEMETRY PT. THE MULTIVIEW WORKSTATION WAS OPERATING WITHOUT ANY PROBLEMS PRIOR TO THE LOSS OF TELEMETRY MONITORING FOR THIS PT. AFTER RESTORING THE RECEIVER SETUP DATA THROUGH THE MULTIVIEW WORKSTATION, TELEMETRY MONITORING WAS RESTORED ALTHOUGH GAPS EXISTED IN THE FULL DISCLOSURE DATABASE RECORD FOR THE TIME THAT THE TELEMETRY MONITORING WAS DOWN. THE CUSTOMER IS CONCERNED THAT THE LOSS OF TELEMETRY MONITORING UNDER THESE CONDITIONS DID NOT GENERATE ANY AUDIBLE OR VISUAL ALARMS AND THE LOSS OF TELEMETRY MONITORING WENT UNNOTICED FOR A PERIOD OF TIME AND IS CONCERNED THAT THIS REPRESENTS A POTENTIAL PT SAFETY ISSUE. A DRAEGER TECHNICAL SERVICE REP WAS DISPATCHED TO THE CUSTOMER'S SITE AND WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVIEW WORKSTATION CENTRAL STATION PATIENT MONITORING SYSTEM DSI DRAEGER MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI