BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ULTRAVIEW SL CENTRAL MONITOR

    MDR report key: 6557390 · Received May 10, 2017

    Report

    Report Number
    3010157426-2017-00041
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    April 3, 2017
    Report Date
    May 10, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K102422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVENT, STAFF CONFIRM OTHER BEDSIDE ALARMS WERE OCCURRING AT THE CENTRAL MONITOR AND THE CUSTOMER BIOMED RESTORED ALARMS AT THE CENTRAL FOR THE BEDSIDE DEVICE IN QUESTION BY PERFORMING A SCREEN FORMAT. SPACELABS WAS NOTIFIED A WEEK AFTER THE EVENT OCCURRED, AND AN INVESTIGATION WAS IMMEDIATELY LAUNCHED. HOWEVER, DUE TO THE LENGTH OF TIME THAT HAD PASSED, THE PATIENT'S HISTORICAL DATA AND TREND INFORMATION WAS NO LONGER AVAILABLE. A SPACELABS FIELD SERVICE ENGINEER ARRIVED TO INVESTIGATE ONSITE. CLINICAL STAFF STATED ALARMS WERE HEARD DURING THE EVENT FROM THE BEDSIDE MONITOR, HOWEVER A DECISION WAS MADE BY THE CUSTOMER TO REMOVE THE TWENTY ONE YEAR OLD BEDSIDE MONITOR FROM SERVICE FOLLOWING THE EVENT. BIOMEDICAL STAFF DECLINED TO PROVIDE APPROVAL TO TEST THE INVOLVED BEDSIDE AND CENTRAL MONITOR, THEREFORE SPACELABS IS UNABLE TO INVESTIGATE ANY FURTHER. THE BEDSIDE MONITOR IS CONSIDERED THE PRIMARY ALARM NOTIFICATION DEVICE. CONFIRMATION WAS RECEIVED THAT THE BEDSIDE MONITOR DID GENERATE ALARMS DURING THE EVENT. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE MATTER CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2017, AT 05:38 AM, AN ALARM DID NOT OCCUR AT THE CENTRAL MONITOR DURING A CARDIAC EVENT INVOLVING A PATIENT ON A BEDSIDE MONITOR. ALARMS GENERATED FROM THE PATIENT¿S BEDSIDE MONITOR. THE PATIENT REMAINED HOSPITALIZED AND DIED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339247 SPACELABS ULTRAVIEW SL CENTRAL MONITOR UVSL CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 91387-38

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 90385 ((B)(4))