BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS

    MDR report key: 3125002 · Received May 16, 2013

    Report

    Report Number
    MW5030252
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    January 1, 2012
    Report Date
    May 16, 2013
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING GENERATED TO ALERT YOU TO THE FACT THAT DIFFERENT MODELS OF SPACELAB MONITORS HAVE AN "INABILITY TO LATCH" THUS NOT ALERTING HOSPITAL STAFF TO SIGNIFICANT CARDIAC EVENTS DURING A PT'S HOSPITAL COURSE. OUR ORGANIZATION HAS REACHED OUT TO SPACELABS ON MANY DIFFERENT OCCASIONS AND THEIR BEST ADVICE IS TO CHANGE OUR POLICY AND REQUIRE THAT NURSES VIEW THEIR CARDIAC STRIP OF A PT EVERY 30 MINUTES TO ENSURE THAT NO ADVERSE EVENT OCCURRED DURING THAT TIME. THIS CHANGE WOULD COMPENSATE FOR THE FACT THAT THE ALARM QUITS ALARMING IF THE PT SELF CORRECTS THEIR CARDIAC ISSUE. THE SAME SITUATION OCCURS WITH EACH OF THESE SPACELAB MONITORS. THE NUMBER NEXT OT THE MAKE REPRESENTS THE NUMBER OF MONITORS WE HAVE WITHIN OUR SYSTEM. PT MONITORS 90367-4, 91393-15, 91369-146, 91370-76, 91387-96, 91370-25, 91387-2, 90308-1, 90385-1: TOTAL 366. TELEMETRY TRANSMITTERS 91343-09/41, 91347-09/28: TOTAL 69. DATES OF USE: (B)(6) 2012 - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218440 SPACELABS MONITOR MHX SPACELABS HEALTHCARE 90367

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| O| R