BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 2465022 · Received February 23, 2012

    Report

    Report Number
    3023361-2012-00006
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 28, 2012
    Report Date
    June 22, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K050605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL TESTING CARRIED OUT BY THE SPACELABS FIELD SERVICE ENGINEER (FSE) AT THE CUSTOMER'S SITE CONFIRMED THE PATIENT MONITOR WAS OPERATING TO SPECIFICATIONS. SPACELABS IS WORKING WITH THE CUSTOMER TO COLLECT MORE DATA TO CONTINUE OUR INVESTIGATION. AT THIS TIME THERE IS INSUFFICIENT DATA TO IDENTIFY ROOT CAUSE OR DRAW ANY CONCLUSION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    TESTING CARRIED OUT BY THE SPACELABS FIELD SERVICE ENGINEER (FSE) ON SITE CONFIRMED THE DEVICE WORKED TO SPECIFICATIONS. A COPY OF WAVEFORM SHOWING AN EPISODE OF VENTRICULAR TACHYCARDIA WAS ANALYZED BY A SPACELABS ENGINEER. THE MORPHOLOGY OF THE WAVEFORM CHANGED FREQUENTLY AND SEVERAL LOW AMPLITUDE BEATS COULD HAVE CAUSED THE WAVEFORM TO NOT MEET THE CRITERIA FOR THE NUMBER OF CONSECUTIVE BEATS TO ALARM. WITH RESPECT TO THE REPORTED FAILURE TO ALARM FOR A LOW BLOOD PRESSURE CONDITION, AN ALARM WILL ONLY BE INITIATED WHEN BLOOD PRESSURE CONTINUOUSLY EXCEEDS THE ALARM THRESHOLD FOR A MINIMUM OF 3 SECONDS IN ORDER TO MINIMIZE NUISANCE ALARMS CAUSED BY TRANSIENT PRESSURE CHANGES. PRESSURE MEASUREMENTS ARE CALCULATED USING AN AVERAGING FUNCTION THAT IS BASED ON HEART RATE. IN THIS CASE, THE AVERAGE PRESSURE MEASUREMENT DID NOT EXCEED THE ALARM THRESHOLD FOR THE MINIMUM TIME REQUIRED FOR AN ALARM. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. THE CUSTOMER IS CONTINUING TO USE THE DEVICE TO MONITOR PATIENTS. WE HAVE CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AND CONSIDER THIS ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR FAILED TO ALARM ON A RUN OF VTAC AND LOW BLOOD PRESSURE IN THE INTENSIVE CARE UNIT.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR FAILED TO ALARM ON VTAC IN THE INTENSIVE CARE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT MONITOR MODEL 91387, SN: (B)(4)| PATIENT MONITOR MODEL 91387, SN: (B)(4)