BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY GATEWAY

    MDR report key: 11322420 · Received February 12, 2021

    Report

    Report Number
    1220063-2021-00004
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    October 25, 2020
    Report Date
    July 6, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K043549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOG FILES FROM THE EVENT WERE NOT AVAILABLE. ALTHOUGH THE LOG FILES WERE NOT AVAILABLE, THE SAME SCENARIO AT CUSTOMER SITE WAS REPRODUCED, AND LOG FILES FROM THIS EVENT WERE REVIEWED. AFTER REPRODUCING THE WORK FLOW FOUND IN THE LOG FILES BY SIMULATING MULTIPLE ALARMS FORM THE BEDSIDE AND VENT SIMULTANEOUSLY, IT WAS FOUND THAT ONLY THE HIGHEST GRADE ALARM WAS SENT OVER THE NETWORK. AFTER REVIEW BY SW ENGINEERING, IT WAS FOUND THAT THE DEVICE BEHAVED AS DESIGNED. THE INFINITY NETWORK DOES NOT PROVIDE THE ABILITY TO SEND OUT ALL ACTIVE ALARMS. THE GATEWAY INSTRUCTIONS FOR USE (IFU) STATES THE DEVICE PROVIDES THE FOLLOWING CAPABILITIES: - "RETRIEVE THE SELECTED INFINITY MONITOR'S CURRENT HIGHEST GRADE ALARM INFORMATION, INCLUDING ALARM STATE, ALARM GRADE, ALARM MESSAGE, AND TIME OF ALARM." - "RETRIEVE THE SELECTED INFINITY MONITOR'S CURRENT HIGHEST GRADE VENTILATOR ALARM INFORMATION (IF AVAILABLE), INCLUDING ALARM STATE, ALARM GRADE, ALARM MESSAGE, AND TIME OF ALARM." THERE WAS NO ALLEGATION OF A DRAEGER DEVICE MALFUNCTION. THE CUSTOMER HAS ADOPTED A WORKAROUND BY GETTING RID OF THE GATEWAY CONNECTION AND GOING DIRECTLY TO THE ASCOM SYSTEM USING THE ENOVACOM PATIENT CONNECT INTERFACE. THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: SIMULTANEOUS EVENTS FROM IACS/V500 ARE HIDDEN ON ASCOM'S MYCO 2 WHEN OCCURRING ON THE SAME PATIENT. ----------------------------------------------- OVERVIEW OF INSTALLATION AND CONNEXIONS: - IACS C700 AND VENTILATOR V500 CONNECTED TOGETHER THROUGH CAPSULE DIM. - ALL IACS SEND INFORMATIONS TO INFINITY GATEWAY FOR CONVERSION. - INFINITY GATEWAY (WINACCESS OPTION) SEND INFORMATION TO 3RD PART SYSTEM (ENOVACOM SOFTWARE) FOR MANAGING ALARMS (ASCOM SOFTWARE) ISSUE REPORTED: ON (B)(6) 2020 AROUND 5H17 PM SOME ALARMS SENT TO 3RD PART DEVICES ACCORDING TO "HIGHTEST ALARMS" MANAGED BY WINACCESS SOFTWARE. THIS PROCESS CAUSED A LACK OF ALARM FOR ASCOM PART : SOME YELLOW ALARMS ("LOW MV") WAS HIDDEN BY A "VENTILATOR DISCONNECTION" (RED ALARM). WHEN RED ALARMS ACKNOWLEDGED BY USERS SOME YELLOW ALARMS COULD BE REACHED TOO LATER, AN ASYSTOLE ALARM HAPPENED FEW TIMES LATER YELLOW ALARMS (5H27 PM) PATIENT COULD BE REANIMATED AND INJURY IS NOT DIRECTLY RELATED TO DRAEGER'S DEVICE BUT MORE "ALARM MANAGEMENT SYSTEM". THIS CUSTOMER COMPLAINED ABOUT INFINITY GATEWAY BECAUSE IT SEND ONLY "HIGHTEST ALARM" BY BEDS. IT IS NOT COMPATIBLE WITH A FULL "ALARM MANAGEMENT SYSTEM" THAT REQUIRED ALL SIMULTANEOUS ALARMS FOR EACH BEDS. ISSUE IS QUITE OLD AND WE COULDN'T GET LOGS WHEN HAPPENED. TO HELP YOU WE CAN GENERATE SAME SCENARIO AT CUSTOMER SITE AND GET YOU ALL LOGS NECESSARY.

    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: SIMULTANEOUS EVENTS FROM IACS/V500 ARE HIDDEN ON ASCOM'S MYCO 2 WHEN OCCURRING ON THE SAME PATIENT. OVERVIEW OF INSTALLATION AND CONNEXIONS: IACS C700 AND VENTILATOR V500 CONNECTED TOGETHER THROUGH CAPSULE DIM. ALL IACS SEND INFORMATIONS TO INFINITY GATEWAY FOR CONVERSION. INFINITY GATEWAY (WINACCESS OPTION) SEND INFORMATION TO 3RD PART SYSTEM (ENOVACOM SOFTWARE) FOR MANAGING ALARMS (ASCOM SOFTWARE) ISSUE REPORTED: ON (B)(6) 2020 AROUND 5H17 PM SOME ALARMS SENT TO 3RD PART DEVICES ACCORDING TO "HIGHTEST ALARMS" MANAGED BY WINACCESS SOFTWARE. THIS PROCESS CAUSED A LACK OF ALARM FOR ASCOM PART : SOME YELLOW ALARMS ("LOW MV") WAS HIDDEN BY A "VENTILATOR DISCONNECTION" (RED ALARM). WHEN RED ALARMS ACKNOWLEDGED BY USERS SOME YELLOW ALARMS COULD BE REACHED TOO LATER, AN ASYSTOLE ALARM HAPPENED FEW TIMES LATER YELLOW ALARMS (5H27 PM) PATIENT COULD BE REANIMATED AND INJURY IS NOT DIRECTLY RELATED TO DRAEGER'S DEVICE BUT MORE "ALARM MANAGEMENT SYSTEM". THIS CUSTOMER COMPLAINED ABOUT INFINITY GATEWAY BECAUSE IT SEND ONLY "HIGHTEST ALARM" BY BEDS. IT IS NOT COMPATIBLE WITH A FULL "ALARM MANAGEMENT SYSTEM" THAT REQUIRED ALL SIMULTANEOUS ALARMS FOR EACH BEDS. ISSUE IS QUITE OLD AND WE COULDN'T GET LOGS WHEN HAPPENED. TO HELP YOU WE CAN GENERATE SAME SCENARIO AT CUSTOMER SITE AND GET YOU ALL LOGS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221765 INFINITY GATEWAY BEDSIDE INFORMATION SYSTEM APPLICATION SOFTWARE MHX DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening