BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE

    MDR report key: 1061342 · Received June 9, 2008

    Report

    Report Number
    1061342
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 30, 2008
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, "NO DETERMINATION" AND "TOTAL TIMEOUT" MESSAGES APPEARED. UNABLE TO MONITOR PATIENT BLOOD PRESSURE, UNTIL SWITCHED TO A DIFFERENT MFR'S MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE MONITOR, MULTI-PARAMETER MODULE MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES * *
    2 TRAM MONITOR, MULTIPARAMETER MODULE MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 400 SL *

    Patients

    Seq Age Sex Outcome Treatment
    1 *