BEUDAMED
    FDA Adverse Event Death Summary report: N

    SC6002XL

    MDR report key: 655799 · Received December 21, 2005

    Report

    Report Number
    1220063-2005-00028
    Event Type
    Death
    Date Received
    December 21, 2005
    Date of Event
    December 9, 2005
    Report Date
    December 21, 2005
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL COMPLAINT DESCRIPTION AND ADDITIONAL INFORMATION RECEIVED FROM OUR LOCAL OFFICE INDICATED THAT THE USER HAD SETUP THE BEDSIDE PATIENT MONITOR (IDENTIFIED IN THE COMPLAINT) WITH THE ALARMS TURNED "OFF" FOR THE PATIENT PARAMETERS BEING MONITORED. IT WAS ALSO INDICATED THA THE USER EXPECTED THAT THE CENTRAL STATION MONITOR WOULD INDICATE AN ALARM STATUS IF THE PATIENT'S CONDITION EXCEEDED THE ESTABLISHED PHYSIOLOGICAL MONITORING PARAMETERS. BY DESIGN, IF THE BEDSIDE PATIENT MONITOR ALARMS ARE TURNED "OFF" FOR THE SELECTED PATIENT PARAMETERS, THOSE ALARMS WILL NOT BE SENT TO THE CENTRAL STATION MONITOR. AS PART OF OUR INVESTIGATION A REVIEW OF THE BEDSIDE MONITOR DEVICE INFORMATION AND THE CENTRAL STATION DEVICE LOGS WAS PERFORMED. THE RESULTS OF THE BEDSIDE PATIENT MONITOR SETUP INFORMATION FOR THE PATIENT BED IN QUESTION, SHOWED THAT ALL MONITORING PARAMETER ALARMS WERE SET TO "OFF" EXCEPT FOR THE HEART RATE (HF) ALARM WHICH WAS SET TO "ON". THE BEDSIDE MONITOR PATIENT TREND DATA TREND DATA SHOWED THAT AN ASYTOLE EVENT WAS DETECTED AND RECORDED FROM 23:33 HR. TO 23:40 HR. ON DECEMBER 8, 2005. IN ADDITION, A CENTRAL STATION ALARM STRIP RECORDING (ALSO SUPPLIED WITH THE COMPLAINT) FOR THE IDENTIFIED PATIENT HAD RECORDED AN ASYTLOE EVENT, WHICH OCCURRED AT THE REPORTED TIME OF THE PATIENT EVENT. THE CENTRAL STATION MONITOR ALARM HISTORY LOGS RECORDED MULTIPLE "ALARM SILENCE TIMER" AND "ALARM SILENCE TIMER RESET" FUNCTIONS HAD BEEN ACTIVATED BY THE USER PRIOR TO AND DURING THE REPORTED PATIENT EVENT. THIS INFORMATION INDICATES THAT THE CENTRAL STATION MONITOR WAS ACTIVELY ALARMING DURING THIS TIME FRAME. BASED ON OUR ANALYSIS OF THE INFORMATION RECEIVED IN ASSOCIATION WITH THE REPORTED EVENT, BOTH THE BEDSIDE AND CENTRAL STATION PATIENT MONITORS RECORDED AN ASYTOLE EVENT WHICH RESULTED IN AN ALARM CONDITION THAT OCCURRED AT THE SAME TIME OF THE REPORTED PATIENT EVENT. IN ADDITION, THE ALARM LOG FROM THE CENTRAL STATION RECORDED ALARM SILENCING ACTIONS BY THE USER AT THE SAME TIME AS THE REPORTED PATIENT EVENT. AS A RESULT OF OUR ANALYSIS OF THE DEVICE INFORMATION THAT WAS PROVIDED FOR THE REPORTED PATIENT EVENT AND THE RESULTS OF THE DEVICE TESTING AT THE CUSTOMER SITE BY OUR LOCAL SERVICE REPRESENTATIVE, WE CONCLUDE THAT OUR BEDSIDE AND CENTRAL STATION PATIENT MONITORING SYSTEM WAS FUNCTIONING AS DESIGNED. THE CENTRAL STATION MONITOR ALARM HISTORY LOGS RECORDED MULTIPLE ALARM SILENCING AND TIMER SET ACTIONS WITHIN MINUTES OF EACH OTHER AROUND THE SAME TIME AS THE REPORTED PATIENT EVENT. THIS CLEARLY INDICATES THAT THE ALARM SYSTEM WAS ACTIVE AND FUNCTIONING AS DESIGNED. THE REPORTED EVENT COULD BE THE RESULT OF MORE THAN ONE BEDSIDE PATIENT MONITOR IN AN ALARM STATE AT THE SAME TIME AS THE BED IN QUESTION, WHICH MAY HAVE BEEN UNINTENTIONALLY MISSED BY THE USER. BASED ON THE RESULTS OF OUR INVESTIGATION, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NO PT ALARMS WERE COMMUNICATED TO THE MULTIVIEW WORKSTATION CENTRAL STATION MONITOR, WHICH WAS NETWORKED TO THE PT BEDSIDE MONITOR. THE PT WAS FOUND TO HAVE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC6002XL BEDSIDE PHYSIOLOGICAL PT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. SC6002XL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death