BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 5086396 · Received September 17, 2015

    Report

    Report Number
    3010157426-2015-00172
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 19, 2015
    Report Date
    November 16, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT SPACELABS¿ EQUIPMENT SERVICE CENTER FOR REPAIR. THE REPORTED PROBLEM WAS VERIFIED. PART NUMBERS 333-0919-01 REAR MODULE PANEL, 670-0982-04 PCBA CPU WITH MPC 860 AND SDRA WERE USED TO REPLACE THE NON-FUNCTIONING ECG COMPONENTS. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER. LACK OF A CONSISTENT ECG TRACE WAS THE WARNING SIGN THAT THE CUSTOMER NOTICED AND THAT PROMPTED THE ACTION OF REMOVING THE PRODUCT FROM USE. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED. SPACELABS MONITORS ITS COMPLAINTS FOR SIMILAR PRODUCT ISSUES TO DETERMINE NEED FOR ADDITIONAL INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS ISSUE AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED COMMAND MODULE MODEL 91496 FOR SERVICE REPAIR WITH CUSTOMER COMPLAINT OF "ECG KEEPS GOING ON AND OFF". THE CUSTOMER REMOVED THE PRODUCT FROM SERVICE ON (B)(6) 2015. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616840 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW SL MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1