BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 2477696 · Received March 5, 2012

    Report

    Report Number
    3023361-2012-00008
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    January 16, 2012
    Report Date
    March 3, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K050605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD A CONCERN THE PATIENT MONITOR DID NOT ALARM AS DOCUMENTED IN THE WAVEFORM DATA FOR THE INTESYS CLINICAL SUITE (ICS) SYSTEM. HOWEVER, THE CUSTOMER STATED THERE WAS NO PATIENT INCIDENT AND TESTING OF THE DEVICE WAS NOT NECESSARY. THE CUSTOMER WAS NOT ABLE TO DETERMINE THE MONITOR USED AT THE TIME OF THE EVENT AND DID NOT PROVIDE THE DEVICE SERIAL NUMBER INFORMATION TO SPACELABS. SPACELABS ENGINEERING REVIEWED WAVEFORMS FROM BOTH THE MONITOR AND THE ICS SYSTEM. THE WAVEFORM ANNOTATION PRESENTED BY ICS IS THE RESULTS OF THE ICS RETROSPECTIVE ANALYSIS ALGORITHM, AND IS NOT INTENDED TO IMITATE THE MONITOR'S ALARM FUNCTIONALITY. AS NO ISSUE APPEARED IN THE WAVEFORMS AND AS WE WERE UNABLE TO TEST THE SUSPECT DEVICE, WE WERE NOT ABLE TO CONFIRM A MONITOR ALARM FAILURE. THE CUSTOMER HAS BEEN MADE AWARE THAT THE ALGORITHMS USED BY THE MONITOR AND THE ICS ARE DIFFERENT. THE HOSPITAL IS CONTINUING TO USE THE DEVICE TO MONITOR PATIENTS. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR FAILED TO ALARM ON VTAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1