BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS INC.

    MDR report key: 1167218 · Received September 18, 2008

    Report

    Report Number
    MW5008339
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 18, 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 MONITORED IN THE TELEMETRY UNIT DUE TO A RUN OF V-TACH AFTER A PROCEDURE. UNABLE TO RETRIEVE ARCHIVE DATA FROM THE SPACELAB HEALTHCARE INTESYS CLINICAL SUITE -ICS- "FULL DISCLOSURE" MONITORING INFO SYSTEM. IS CONTACTED SPACELAB TO RESOLVE PROBLEM. DATA WAS RETRIEVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1