BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3959940 · Received June 20, 2014

    Report

    Report Number
    3010157426-2013-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    August 8, 2013
    Report Date
    September 11, 2015
    Manufacturer
    SPACELABS HEALTHCARE, INC.
    Product Code
    DSI
    PMA / PMN Number
    K972502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS REPORTED EVENT. SPACELABS IS EVALUATING THIS REPORTED EVENT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THERE WERE VISUAL ALARMS FOR INVASIVE ARTERIAL PRESSURE (ART) AND FOR INVASIVE CENTRAL VENOUS PRESSURE (CVP), BUT THERE WERE NO AUDIBLE ALARMS. THE CUSTOMER STATED THE ALL OTHER PARAMETERS SOUNDED ALARMS WHEN THE ALARM LIMITS WERE ADJUSTED TO FORCE AN ALARM. THE BIOMED TESTED THE MONITOR WITH ANOTHER MODULE AND IT WORKED NORMALLY. THE MODULE WAS ALSO TESTED IN ANOTHER MONITOR AND IT WORKED NORMALLY. THE MODULE WAS REMOVED FROM SERVICE AND RETURNED TO SPACELABS. SPACELABS WAS NOT MADE AWARE OF THIS INCIDENT UNTIL AUGUST 9, 2013, MORE THAN 30 DAYS AFTER THE OCCURRENCE. BECAUSE OF THIS DELAY WE WERE NOT ABLE TO OBTAIN PATIENT INFORMATION (HISTORY DATA) TO REVIEW. WE WERE NOT PROVIDED THE PRINTOUTS FOR THE ALARM SETTINGS. A SPACELABS FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO TEST THE MONITOR. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM DURING HIS INVESTIGATION. THE HOSPITAL HAS CONTINUED TO USE THE MONITOR SINCE THE INCIDENT. WE TESTED THE MODULE THAT WAS RETURNED BY THE CUSTOMER, BUT WERE UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE ¿ON/OFF¿ CONTROLS FOR ALARM TONES ARE USER ADJUSTABLE. WE WERE UNABLE TO VERIFY THE SETTINGS AS THESE SETTINGS ARE NOT RETAINED AFTER THE MONITOR IS TURNED OFF. HOWEVER, IF THE SETTINGS FOR THESE CONTROLS WERE SET TO ¿OFF¿ AT THE TIME OF THE REPORTED EVENT, THE MONITORING SYSTEM WOULD NOT HAVE PROVIDED AN AUDIBLE ALARM NOTIFICATION. THE ALARM TONE VOLUME SETTING ON THE MONITOR AT THE TIME OF THIS EVENT IS UNKNOWN. THIS INFORMATION WAS NOT RECORDED AT THE TIME OF THE EVENT NOR IS IT POSSIBLE TO INFER THIS INFORMATION BASED ON THE STANDARD MONITOR CONFIGURATION. ALTHOUGH IT IS POTENTIALLY POSSIBLE, WE FIND IT UNLIKELY THAT AN AUDIBLE ALARM FOR THIS EVENT WAS NOT GENERATED AT THE MONITOR. THIS TYPE OF MONITOR BEHAVIOR HAS NOT BEEN OBSERVED IN ANY PREVIOUS TESTING OF OUR MONITORS NOR WERE WE ABLE TO RECREATE THIS SCENARIO DURING THE PRESENT INVESTIGATION. IN CONCLUSION, WE ARE UNABLE TO IDENTIFY ANY TECHNICAL PROBLEMS AND CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED FAILURE. WE CONTINUE TO MONITOR PRODUCT COMPLAINTS AND WORK CLOSELY WITH THE CUSTOMER TO OFFER OUR SUPPORT AS NECESSARY. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT OF A VISUAL ALARM ON INVASIVE PARAMETERS (ART AND CVP) BUT NO AUDIBLE ALARM.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR, MODEL 91387, FAILED TO ALARM FOR INVASIVE ARTERIAL PRESSURE (ART) AND FOR INVASIVE CENTRAL VENOUS PRESSURE (CVP). NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363415 SPACELABS ULTRAVIEW SL COMMAND MODULE DSI: ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS HEALTHCARE, INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR 91496-C (B)(4)