BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XPREZZON BEDSIDE MONITOR

    MDR report key: 4996393 · Received August 12, 2015

    Report

    Report Number
    3010157426-2015-00157
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 15, 2015
    Report Date
    September 23, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K112962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION OF THIS ISSUE 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. THE CPU PCBA 670-1488-00 WAS NOT FUNCTIONING; THEREFORE, THE PCBA WAS REPLACED. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER. LACK OF POWER UP 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 AN XPREZZON BEDSIDE MONITOR MODEL 91393 THAT STOPPED WORKING WHILE IS USE AND WOULD NOT RESTART ON (B)(6) 2015. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530085 SPACELABS XPREZZON BEDSIDE MONITOR S-CLASS MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91393

    Patients

    Seq Age Sex Outcome Treatment
    1