BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAVIEW COMMAND MODULE

    MDR report key: 1240465 · Received November 19, 2008

    Report

    Report Number
    3023361-2008-00084
    Event Type
    Death
    Date Received
    November 19, 2008
    Date of Event
    October 19, 2008
    Report Date
    November 18, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K972502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS REVIEW OF THE 91496 MODULE CONFIGURATION SHOWED THAT THE VTACH OR RUN ALARM WAS TURNED ON, BUT THAT RECORDING FOR THESE OCCURRENCES WAS SHUT OFF. AS A RESULT, THERE SHOULD HAVE BEEN AN AUDIO AND VISUAL RUN ALARM WHEN THE PT WAS EXPERIENCING A VTACH CONDITION, BUT NO AUTO RECORDING. AS THE PT'S CONDITION DETERIORATED, THE MODULE DID ALARM PROPERLY FOR VFIB AND ASYSTOLE CONDITIONS. OUR INVESTIGATION INTO THIS EVENT IS CONTINUING. WE WILL PROVIDE AN UPDATE WITH OUR FINAL INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    HOSP STAFF STATED THAT A SPACELABS 91496 MODULE DID NOT ALARM WHEN A PT EXPERIENCED A VTACH CONDITION. THE PT WAS UNDER DNR (DO NOT RESUSCITATE) ORDERS, AND DIED AFTER THE EVENT. THE MONITOR DID ALARM FOR VFIB AND ASYSTOLE CONDITIONS AND RECORDED THESE CONDITIONS TO A CORRESPONDING STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVIEW COMMAND MODULE NONE MHX SPACELABS HEALTHCARE 91496-1BHNS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O