BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY CENTRAL STATION

    MDR report key: 8964919 · Received September 5, 2019

    Report

    Report Number
    1220063-2019-00016
    Event Type
    Death
    Date Received
    September 5, 2019
    Date of Event
    August 7, 2019
    Report Date
    November 25, 2019
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K130711
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS REANIMATED BUT LATER DIED. M300 LOGS WERE NOT AVAILABLE TO IDENTIFY THE SPECIFIC ALARMS GENERATED. FULL DISCLOSURE AND ECG STRIP WERE REVIEWED AND NO ASYSTOLE CONDITION WAS SEEN. FURTHERMORE, THE ICS LOGS DO NOT INDICATE THE USER WAS ACTIVELY SILENCING ALARMS AT THE TIME OF EVENT WHICH AGREES WITH THE FULL DISCLOSURE AND ECG STRIPS, AS NO EVENTS WERE GENERATED OR DETECTED. BASED ON THE AVAILABLE INFORMATION, THE ISSUE COULD NOT BE VERIFIED, AND NO MALFUNCTIONS WERE DETERMINED TO HAVE OCCURRED WITH DRAEGER¿S PRODUCTS. BOTH THE M300 AND THE ICS WERE TESTED PRIOR TO BEING PUT BACK INTO USE AND NO PROBLEMS WERE FOUND. THE ISSUE IS ISOLATED. THERE IS NO INFORMATION THAT INDICATES OUR DEVICE PLAYED A FACTOR IN THE PATIENTS DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PATIENT EVENT AT APPROXIMATELY 1:13 IN THE MORNING, THE M300 TELE 4 DID NOT TRANSMIT AN ASYSTOLE ALARM TO THE INFINITY CENTRAL STATION. THE RESUSCITATION TEAM OF THE INTENSIVE CARE UNIT WAS INFORMED AT 1:15, AFTER THAT THE ALARMS WERE AUDIBLE. IT WAS REPORTED THAT THE PATIENT IS DYING, WHETHER THERE IS A CONNECTION BETWEEN THIS EVENT AND THE PATIENT'S CONDITION IS UNKNOWN. ADDITIONAL DETAILS PROVIDED: DEVICE IS OPERATED WITH BLACKBOX EXTENDER ACU5116. ICS IS LOCATED IN THE SERVER ROOM, IT WAS CHECKED THAT THE ALARMS ARRIVE AT THE INTENSIVE STATION AND STATION 13A. AN INSPECTION OF THE ENTIRE SYSTEM WILL BE DONE AFTER COMMISSIONING BY THE HOSPITAL'S MEDICAL TECHNOLOGY DEPARTMENT NEXT MONDAY. UNTIL THEN, THE ENTIRE SYSTEM WILL NOT BE USED. THE ICS LOG HAS BEEN SAVED. THE PATIENT HAS ALREADY BEEN DISCHARGED FROM THE M300. LOGS THEREFORE NO LONGER AVAILABLE, NO EVENTS FOR THE ABOVE MENTIONED TIME IN EVENT MODE, LONG-TERM DATA PRINTOUT ATTACHED. USER ALSO COMPLAINS ABOUT A FAULTY POWER CABLE OF THE CENTRAL CHARGER (DATE: (B)(6) 2019), BUT PRESUMABLY NOT RELATED TO THIS EVENT). IT WAS REPLACED BY THE MEDICAL TECHNOLOGY OF THE HOUSE, THEN IN THE CENTRAL CHARGER ASYSTOLE ALARMS WERE TRIGGERED ON SEVERAL M300 DEVICES. THE PATIENT DIDN'T HAVE A PACEMAKER.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT EVENT AT APPROXIMATELY 1:13 IN THE MORNING, THE M300 TELE 4 DID NOT TRANSMIT AN ASYSTOLE ALARM TO THE INFINITY CENTRAL STATION. THE RESUSCITATION TEAM OF THE INTENSIVE CARE UNIT WAS INFORMED AT 1:15, AFTER THAT THE ALARMS WERE AUDIBLE. IT WAS REPORTED THAT THE PATIENT IS DYING, WHETHER THERE IS A CONNECTION BETWEEN THIS EVENT AND THE PATIENT'S CONDITION IS UNKNOWN. ADDITIONAL DETAILS PROVIDED: DEVICE IS OPERATED WITH BLACKBOX EXTENDER ACU5116. ICS IS LOCATED IN THE SERVER ROOM, IT WAS CHECKED THAT THE ALARMS ARRIVE AT THE INTENSIVE STATION AND STATION 13A. AN INSPECTION OF THE ENTIRE SYSTEM WILL BE DONE AFTER COMMISSIONING BY THE HOSPITAL'S MEDICAL TECHNOLOGY DEPARTMENT NEXT MONDAY. UNTIL THEN, THE ENTIRE SYSTEM WILL NOT BE USED. THE ICS LOG HAS BEEN SAVED. THE PATIENT HAS ALREADY BEEN DISCHARGED FROM THE M300. LOGS THEREFORE NO LONGER AVAILABLE, NO EVENTS FOR THE ABOVE MENTIONED TIME IN EVENT MODE, LONG-TERM DATA PRINTOUT ATTACHED. USER ALSO COMPLAINS ABOUT A FAULTY POWER CABLE OF THE CENTRAL CHARGER (DATE: (B)(6) 2019), BUT PRESUMABLY NOT RELATED TO THIS EVENT). IT WAS REPLACED BY THE MEDICAL TECHNOLOGY OF THE HOUSE, THEN IN THE CENTRAL CHARGER ASYSTOLE ALARMS WERE TRIGGERED ON SEVERAL M300 DEVICES. THE PATIENT DIDN'T HAVE A PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759540 INFINITY CENTRAL STATION PHYSIOLOGICAL MONITORING SYSTEM MHX DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L