BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW PT MONITOR

    MDR report key: 3931248 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00030
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    March 2, 2014
    Report Date
    September 11, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED TO SPACELABS 10 DAYS AFTER OCCURENCE. THE PT DATA IS NOT AVAILABLE BECAUSE THE CUSTOMER'S RETROSPECTIVE DATABASE (ICS SYSTEM) PURGES DATA AFTER 72 HRS. THE SCREENSHOTS OF THE ICS PROVIDED BY THE CUSTOMER CANNOT BE USED FOR EVALUATION BECAUSE THEY ARE FROM THE SAVED EVENTS NOT THE ALARMS TAB IN THE ICS SYSTEM. HENCE NO ALARMS INFO IS AVAILABLE. NONE OF THE PT WAVEFORM PRINTOUT SHOWS THE WAVEFORM AT THE TIME OF THE INCIDENT. THE DEVICES INVOLVED IN THE EVENT WERE TESTED BY A SPACELABS FIELD SERVICE ENGINEER (FSE) ONSITE WITH NO PROBLEM FOUND. THE FSE FOUND SEVERAL OTHER PATIENTS ON TELEMETRY WITH "???" FOR THE HEART RATE AND MONITOR MESSAGES STATING THERE WAS A BAD LEAD CONNECTION. THE FSE REPLACED THE LEAD WIRES, AND DISCUSSED LEAD PREPARATION WITH THE CUSTOMER. THE CUSTOMER IS CONTINUING TO USE THE SUBJECT DEVICES TO MONITOR PATIENTS. SPACELABS CONSIDERS THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY MONITOR FAILED TO ALARM WHEN A PT WAS HAVING ARRHYTHMIAS. THE MONITOR TECHS NOTICED THAT THE MONITOR WAS SHOWING "???" INSTEAD OF PT HEART RATE DURING THE EVENT. THE PT WENT INTO A CODE AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364301 SPACELABS ULTRAVIEW PT MONITOR MHX: MULTIPARAMETER PT MONITOR MHX SPACELABS HEALTHCARE INC. 91387

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death MODULE RECEIVER, MODEL 90478,| SN (B)(4)