BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS INC, FIRST

    MDR report key: 1167333 · Received September 17, 2008

    Report

    Report Number
    MW5008353
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 17, 2008
    Manufacturer
    SPACELAB 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

    PT ADMITTED FOR CARDIAC RHYTHM MONITORING. PHYSICIAN UNABLE TO RETRIEVE ARCHIVE DATA FROM SPACELAB HEALTHCARE INTESYS CLINICAL SUITE - ICS- "FULL DISCLOSURE" MONITORING INFO SYSTEM. INFO SYSTEMS - IS- WAS ABLE TO RESTORE DATA, BUT UNABLE TO CORRECT MALFUNCTION. IS DETERMINED THE "FULL DISCLOSURE" COMPONENT OF THE MONITORING SYSTEM IS ON A RUNNING CLOCK. ONCE THE DATA IS RETRIEVED, IT MUST BE REVIEWED IMMEDIATELY, OR THE DATA WILL BE LOST OVER TIME. THE DATA AT THE BEGINNING OF THE MONITORING PERIOD WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS INC, FIRST INTESYS CLINICAL SUITE SPACELAB INFORMATION SYSTEM MHX SPACELAB HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1