BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS HEALTHCARE INC INTESYS CLINICAL SUITE

    MDR report key: 1170067 · Received September 19, 2008

    Report

    Report Number
    MW5008367
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 19, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO ACCESS SPACELAB HEALTHCARE INTESYS CLINICAL SUITE -ICS- "FULL DISCLOSURE" MONITORING INFO SYSTEM. TEN -10- HOURS OF CARDIAC MONITORING INFO WAS NOT AVAILABLE ON ELEVEN -11- PTS IN THE CARDIAC INTENSIVE CARE AND TELEMETRY UNITS. INFO SYSTEMS NOTIFIED SPACELABS OF ISSUE. DATA WAS RESTORED 2 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS HEALTHCARE INC INTESYS CLINICAL SUITE FULL DISCLOSURE MONITORING SYSTEM SOFTWEAR MHX SPACELABS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1