BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 3767355 · Received April 23, 2014

    Report

    Report Number
    3010157426-2014-00038
    Event Type
    Death
    Date Received
    April 23, 2014
    Date of Event
    March 22, 2014
    Report Date
    August 19, 2014
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT¿S RHYTHM WENT TO TACHYCARDIA AND THEN ASYSTOLE; THERE WERE NO AUDIBLE ALARMS DURING THE PROGRESSION OF THIS PATIENT¿S RHYTHM CHANGES. THE PATIENT HAD A DO NOT RESUSCITATE (DNR) ORDER AND PASSED AWAY. ¿STACKED¿ ALARMS IS AN ALARM NOTIFICATION PROVIDED WHEN AN ALARM CONDITION ESCALATES WITHOUT INTERRUPTION FROM ONE ALARM TO ANOTHER. THE STACKED MESSAGE IS INCLUDED IN THE RETROSPECTIVE ALARM CLINICAL VIEW DATABASE. THE STACKED NOTIFICATION DOES NOT CHANGE HOW THE TELEMETRY SYSTEM AND CENTRAL STATION OPERATE OR REPORT ALARMS. SPACELABS SENT A FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE DEVICE ONSITE AND OBTAIN ADDITIONAL INFORMATION FROM THE CLINICAL STAFF. THE MONITOR WAS ALREADY IN USE ON OTHER PATIENTS. THE FSE WAS NOT ALLOWED BY THE HOSPITAL TO TEST THE INCIDENT DEVICES. THERE HAVE BEEN NO FURTHER ISSUES WITH ALARMS. WE REVIEWED THE FULL DISCLOSURE (ICS) DATABASE THAT WAS PROVIDED BY THE CUSTOMER. THERE WAS A RECORD OF A HIGH-PRIORITY ALARM EVENT THAT BEGAN ON (B)(6) AT 5:34:39 AM AND LASTED 1,281 SECONDS. THERE WERE 16 LOW HEART RATE ALARMS AND 14 ASYSTOLE ALARMS OBSERVED DURING THE EVENT. 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 TELEMETRY CENTRAL 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. WE FIND IT UNLIKELY THAT AN AUDIBLE ALARM FOR THIS EVENT WAS NOT GENERATED AT THE TELEMETRY CENTRAL MONITOR IF THE ALARMS TONES WERE TURNED ON. THIS TYPE OF SYSTEM BEHAVIOR HAS NOT BEEN OBSERVED IN ANY PREVIOUS TESTING OF OUR CENTRAL MONITORS NOR WERE WE ABLE TO RECREATE THIS SCENARIO DURING THE PRESENT INVESTIGATION. IN CONCLUSION, WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED FAILURE. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A MONITOR TECH WAS WATCHING THE MONITOR DURING THE EVENT. THE PATIENT WAS A DO NOT RESUSCITATE AND THEN PASSED AWAY. A SPACELABS FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE ISSUE ONSITE. THE MONITOR WAS ALREADY IN USE ON OTHER PATIENTS AFTER THE EVENT. THERE HAVE BEEN NO FURTHER ISSUES WITH ALARMS. THE CUSTOMER WAS UNABLE TO LOCATE THE MONITOR USED DURING THE EVENT. THEREFORE NO TESTING WAS DONE. SPACELABS IS CURRENTLY EVALUATING THE PATIENT RETROSPECTIVE DATA. THE INVESTIGATION IS UNDERWAY. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT MONITOR FAILED TO ALARM FOR TACHYCARDIA AND ASYSTOLE. THE CUSTOMER DID FIND ¿STACKED¿ ALARMS IN THEIR RETROSPECTIVE DATABASE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY PATIENT MONITOR FAILED TO ALARM FOR TACHYCARDIA AND ASYSTOLE. THE CUSTOMER DID FIND ¿STACKED¿ ALARMS IN THEIR RETROSPECTIVE DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246895 SPACELABS DIGITAL TELEMETRY TRANSMITTER TELEMETRY TRANSMITTER DSI SPACELABS HEALTHCARE INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)