BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XPREZZON BEDSIDE MONITOR

    MDR report key: 3959932 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00025
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    March 3, 2014
    Report Date
    February 4, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K112962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS UNDERWAY. SPACELABS WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED.

    Additional Manufacturer Narrative · 1

    THE REGIONAL SERVICE MANAGER (RSM) AND A CLINICAL EDUCATIONAL CONSULTANT (CEC) WERE DISPATCHED TO THE FACILITY TO REVIEW THE EVENT. THE CUSTOMER PROVIDED PATIENT RETROSPECTIVE DATA. UPON REVIEW OF THIS DATA WITH THE CUSTOMER, THE CEC FOUND THE MONITOR ALARMED FOR ASYSTOLE AT THE DESIGNATED TIME FOR AN EVENT LASTING 4.8 SECONDS. THIS EVENT IS 0.3 SECONDS LONGER THAN THE LONGEST ALARM SETTING ON THE SPACELABS¿ PRODUCT FOR AN ECG PAUSE, SO DID NOT REGISTER AS SUCH. THE EVENT DID, HOWEVER, FALL WITHIN SPACELABS¿ DEFINITION OF AN ASYSTOLE ALARM. THE ASYSTOLE ALARM WAS CAPTURED IN THE RETROSPECTIVE DATABASE AT THE REPORTED TIME. ADJACENT TO THE EVENT TIME IN THE RETROSPECTIVE DATABASE WAS A PAUSE ALARM RESULTING FROM ANOTHER PATIENT EVENT. THE CEC EXPLAINED TO THE CUSTOMER HOW TO LOCATE EVENTS IN THE RETROSPECTIVE DATABASE. TO SUMMARIZE, THERE WAS NO DEVICE MALFUNCTION. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR, MODEL 91393, FAILED TO ALARM ON A PAUSE. HOWEVER, THE ALARM WAS CAPTURED IN THE HOSPITAL'S RETROSPECTIVE DATABASE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR XPREZZON MODEL 91393 WITH COMMAND MODULE 91496 FAILED TO ALARM FOR AN ECG PAUSE AT 8:53 A.M. ON (B)(6) 2014; HOWEVER, THE ALARM WAS CAPTURED IN THE PATIENT RETROSPECTIVE DATABASE. NO ONE WAS INJURED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363560 SPACELABS XPREZZON BEDSIDE MONITOR S-CLASS MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE INC. 91393

    Patients

    Seq Age Sex Outcome Treatment
    1