BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12340391 · Received August 18, 2021

    Report

    Report Number
    8030229-2021-01477
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 20, 2021
    Report Date
    April 18, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AROUND 10:15 AM ((B)(6) TIME) THE CENTRAL NURSE'S STATION (CNS) SHUT OFF AND THEN REBOOTED. THE CUSTOMER STATED THAT AT 10:13 AM, THEY NOTICED THAT THE PATIENT DATA HAD STOPPED BEING STORED ON THE CNS, AND THEN THE UNIT SHUT OFF. THEY STATED THAT AFTER THE REBOOT THE CNS CAME BACK UP AND IS RUNNING WITHOUT ANY FURTHER ISSUES AND NO ERRORS MESSAGES. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED IF THERE IS A PROBLEM WITH THE HDDS, AND THE CUSTOMER CONFIRMED THE HDDS ARE FINE WITH NO ERRORS OR PROBLEMS. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. TELEMETRY TRANSMITTER(S) - GZ SERIES: MODEL: NI, SN: NI.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT AROUND 10:15 AM (HAWAII TIME) THE CENTRAL NURSE'S STATION (CNS) SHUT OFF AND THEN REBOOTED. THE CUSTOMER STATED THAT AT 10:13 AM, THEY NOTICED THAT THE CNS STOPPED STORING PATIENT DATA, AND THEN THE UNIT SHUT OFF. AFTER REBOOTING THE CNS, IT WAS UP AND RUNNING WITH NO FURTHER ISSUES. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED IF THERE IS A PROBLEM WITH THE HDDS, AND THE CUSTOMER CONFIRMED THE HDDS ARE FINE WITH NO ERRORS OR PROBLEMS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: DEVICE LOGS WERE COLLECTED AND SENT TO NIHON KOHDEN CORPORATION (NKC) FOR ANALYSIS, AND IT WAS FOUND THAT THE WATCHDOG TOOL DETECTED AN ABNORMALITY AT 10:17 ON JULY 20, 2021. IN ORDER TO MAINTAIN MONITORING, THE OPERATING SYSTEM WAS RESTARTED AS A SAFETY FUNCTION AND RETURNED TO NORMAL OPERATION. HOWEVER, NKC WAS UNABLE TO FIND THE CAUSE FROM THE LOGS. NKC CONFIRMED THAT THE EG PATIENT WAS MOVED 5 MINUTES BEFORE THE WATCHDOG WAS ACTIVATED, BUT THE PATIENT MOVEMENT RESULTED IN THE FAILURE. FROM THAT TIME ON, COMMUNICATION ERROR LOGS BEGAN TO APPEAR. THERE MAY HAVE BEEN SOME COMMUNICATION ERROR, BUT THERE WAS NO LOG TO PROVE IT. BASED ON THE GIVEN INFORMATION, FURTHER INVESTIGATION WAS DIFFICULT AND TERMINATED BECAUSE THERE WAS NO ADDITIONAL REQUEST FROM THE CUSTOMER." THE ANALYSIS CONCLUDED THAT THE SHUTDOWN/REBOOT WAS TRIGGERED BY THE WATCHDOG TOOL WHEN AN ABNORMALITY WAS DETECTED. THIS ABNORMALITY IS PRESUMED TO BE RELATED TO COMMUNICATION ERROR, BUT THERE WAS INSUFFICIENT INFORMATION TO CONTINUE THE INVESTIGATION. SERVICE HISTORY FOR THIS SERIAL NUMBER WAS REVIEWED FOR COMMUNICATION AND TRANSFER ISSUES: FIVE INCIDENTS WERE FOUND, RELATING TO PATIENT ADMIT, DISCHARGE (ADT) AND TRANSFER IN APRIL 2021. THERE WERE NO ADDITIONAL ADT INCIDENTS UNTIL THE CNS REBOOT EVENT ON 7/20/2021. THIS INDICATES AN ABNORMAL ADT PROCEDURE. SERVICE HISTORY FOR THIS FACILITY IS REVIEWED FOR PATTERNS OF ADT ISSUES. AFTER APRIL 2021, THERE WAS NO RECURRENCE OF TICKETS WITH "ADMIT," "DISCHARGE," OR "TRANSFER" IN THE SUBJECT LINE. IT IS PRESUMED THAT THE USER WAS UNFAMILIAR WITH THE ADT PROCEDURE. SPONTANEOUS SHUTDOWN OR SPONTANEOUS REBOOT EVENTS OR SHUTDOWN ARE USUALLY REPORTED WHILE THE CNS IS MONITORING PATIENTS AND ARE TRIGGERED BY EITHER A POWER LOSS OR A HARDWARE FAILURE. WHEN THE CNS EXPERIENCES A POWER LOSS, IT CAN BE CAUSED BY A VARIETY OF EVENTS. THESE EVENTS INCLUDE POWER OUTAGES, GENERATOR TESTS, UNINTERRUPTABLE POWER SUPPLY (FAILURE), POWER OUTLET FAILURE. THESE ARE ENVIRONMENTAL FACTORS THAT IMPACT DEVICE FUNCTIONALITY. HARDWARE FAILURE THAT MAY RESULT IN SPONTANEOUS SHUTDOWN OR REBOOT INCLUDES POWER CORD FAILURE, HARD DRIVE FAILURE, AND VARIOUS OTHER ESSENTIAL COMPONENTS OF A COMPUTER SYSTEM SUCH AS THE COOLING FAN, INTERNAL POWER SUPPLY, MOTHERBOARD, CPU, MEMORY, ETC. MOST COMMONLY, HARD DRIVE FAILURES WILL RESULT IN SPONTANEOUS SHUTDOWN OR REBOOT OF THE DEVICE. CAUSES OF HARD DRIVE FAILURES INCLUDE NORMAL HARD DRIVE FAILURE OR FAILURE RESULTING FROM FREQUENT POWER LOSS, INAPPROPRIATE SHUTDOWN/REBOOT PROCEDURE. THE OPERATOR MANUAL OUTLINES SPECIFIC STEPS TO PERFORM A DEVICE SHUTDOWN OR REBOOT. AS WITH ANY DEVICE, THE HARD DRIVE SUPPLIED WITH THE CNS HAS LIMITED DURABILITY. IT IS THE MANUFACTURER'S RECOMMENDATION TO HAVE HARD DRIVES REPLACED EVERY TWO YEARS OR 20,000 HOURS OF USE. AS A MAINTENANCE REMINDER, THE USER IS PROMPTED WITH A MESSAGE ON THE BOTTOM RIGHT OF THE CNS SCREEN TO CHECK HARD DRIVE STATUS ONCE USAGE HAS REACHED 20,000 HOURS.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AROUND 10:15 AM ((B)(6) TIME) THE CENTRAL NURSE'S STATION (CNS) SHUT OFF AND THEN REBOOTED. THE CUSTOMER STATED THAT AT 10:13 AM, THEY NOTICED THAT THE PATIENT DATA HAD STOPPED BEING STORED ON THE CNS, AND THEN THE UNIT SHUT OFF. THEY STATED THAT AFTER THE REBOOT THE CNS CAME BACK UP AND IS RUNNING WITHOUT ANY FURTHER ISSUES AND NO ERRORS MESSAGES. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED IF THERE IS A PROBLEM WITH THE HDDS, AND THE CUSTOMER CONFIRMED THE HDDS ARE FINE WITH NO ERRORS OR PROBLEMS. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT AROUND 10:15 AM (HAWAII TIME) THE CENTRAL NURSE'S STATION (CNS) SHUT OFF AND THEN REBOOTED. THE CUSTOMER STATED THAT AT 10:13 AM, THEY NOTICED THAT THE CNS STOPPED STORING PATIENT DATA, AND THEN THE UNIT SHUT OFF. AFTER REBOOTING THE CNS, IT WAS UP AND RUNNING WITH NO FURTHER ISSUES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232263 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TELEMETRY TRANSMITTER(S)| TELEMETRY TRANSMITTERS