BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW PATIENT MONITOR

    MDR report key: 5050867 · Received September 2, 2015

    Report

    Report Number
    3010157426-2015-00167
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 6, 2015
    Report Date
    October 16, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION IN THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT SPACELABS¿ EQUIPMENT SERVICE CENTER FOR REPAIR. THE REPORTED PROBLEM WAS VERIFIED. AN INTEGRATED CIRCUIT CHIP (IC) PART NUMBER 170-0190-01 NOVRAM AND ROCKER SWITCH PART NUMBER 260-0106-00 WAS NOT FUNCTIONING; THEREFORE, THESE COMPONENTS WERE REPLACED. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER. LACK OF CONSISTENT POWER 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.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REQUEST FOR SERVICE REPAIR FOR BEDSIDE MONITOR MODEL 91387 THAT LOST POWER DURING USE ON (B)(6) 2015 AND WOULD NOT RESTART. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583232 SPACELABS ULTRAVIEW PATIENT MONITOR MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91387

    Patients

    Seq Age Sex Outcome Treatment
    1