BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3922924 · Received June 20, 2014

    Report

    Report Number
    3010157426-2014-00027
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    February 15, 2013
    Report Date
    September 11, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K103142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS FILED DUE TO PATIENT DEATH IDENTIFIED DURING A RETROSPECTIVE REVIEW OF OUR COMPLAINT SYSTEM. THE ISSUE WAS REPORTED TO SPACELABS TWO MONTHS AFTER THE OCCURRENCE. THE PATIENT MONITOR DISPLAY BLANK WHEN A PATIENT WAS CODED IN EMERGENCY ROOM #2. THE NURSE REMOVED THE MODULE AND REPLACED IT WITH A MODULE FROM EMERGENCY ROOM #1. THE MONITOR RETURNED TO NORMAL OPERATION. AFTER THE INCIDENT WAS REPORTED TO SPACELABS, THE QUESTIONABLE MODULE WAS TESTED BY A SPACELABS FIELD SERVICE ENGINEER (FSE) ONSITE WITH NO PROBLEM FOUND. THE FSE WAS UNABLE TO DUPLICATE THE REPORTED SYMPTOM. THE BIOMED RECALLED THAT THERE WAS ONE MONITOR HAVING A LOOSE CABLE AND THE OTHER ONE HAVING A BAD POWER SUPPLY DURING THE EVENT. THE MODULE WAS RETURNED TO SERVICE IN EMERGENCY ROOM #1 AND THERE HAVE BEEN NO FURTHER REPORTS CONCERNING THIS DEVICE. IT IS SPACELABS' POLICY TO SUBMIT A MEDICAL DEVICE REPORT WHENEVER WE BECOME AWARE OF DEATH OF ANY PATIENT CONNECTED TO OUR DEVICES. SPACELABS CONSIDERS THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS REC'D A REPORT THAT A PATIENT MONITOR DISPLAY BLANK WHEN A PATIENT CODED. THE PATIENT PASSED AWAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362529 SPACELABS ULTRAVIEW SL COMMAND MODULE DSI: ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Death VIEW SL DISPLAY, MODEL 94266, S/N (B)(4)| PATIENT MONITOR, MODEL 91387, S/N (B)(4)