BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 10646285 · Received October 7, 2020

    Report

    Report Number
    8030229-2020-00591
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 13, 2020
    Report Date
    May 5, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) WAS SHUT DOWN BECAUSE OF A POWER OUTAGE AT THE HOSPITAL. UPON BOOTING UP, THE CNS HAS A "MONITOR NETWORK SERVICE DISCONNECTED" ERROR MESSAGE. THE CNS WAS BEING USED TO MONITOR PATIENTS AT THE TIME OF THE INCIDENT. UPON FURTHER TROUBLESHOOTING, THE CUSTOMER DETERMINED THE DEVICE EXPERIENCED A HARD DRIVE FAILURE. SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: WHEN A CNS IS UNEXPECTEDLY SHUT DOWN DURING OPERATION, WITHOUT GOING THROUGH THE PROPER SHUTDOWN SEQUENCE, IT COULD CAUSE A HARD DRIVE FAILURE. THERE WAS A POWER OUTAGE AT THE FACILITY. ONE OF THE RAID HARD DRIVES FAILED DUE TO THE IMPROPER SHUTDOWN SEQUENCE, AS A DIRECT RESULT OF THE POWER OUTAGE. THIS IS AN ENVIRONMENTAL ISSUE. THE DEVICE IS DESIGNED WITH A REDUNDANT ARRAY OF TWO HARD DISKS. WHEN ONE HARD DISK FAILS, THE OTHER CAN TAKE OVER. THE MANUFACTURER PROVIDED ALL SITES WITH ".BAT" FILE PATCH WHICH HELPS RECOGNIZE HARD DISK FAILURE AND PROVIDES A WARNING MESSAGE WHEN A HARD DRIVE BEGINS TO FAIL. THE MANUFACTURER ALSO UPDATED DEVICE MANUFACTURING PROCESS TO INCORPORATE THE ".BAT" FILE FUNCTION. LABELING AND OPERATOR'S MANUAL FOR VARIOUS GENERATIONS OF THIS DEVICE RECOMMEND PERIODIC MAINTENANCE OR REPLACEMENT OF HARD DISK DRIVES. THERE IS LOW LIKELIHOOD OF RISKS ASSOCIATED WITH THE USE OF DEFECTIVE DEVICE. IN ORDER FOR THE HARD DISK DRIVE TO CAUSE ADVERSE HEALTH CONSEQUENCES, AN IMPROBABLE SEQUENCE OF USER ERROR AND OTHER EVENTS WOULD ALL NEED TO OCCUR: 1) USER DECLINED TO PERMIT INSTALLATION OF SOFTWARE PATCH; 2) USER FAILS TO RESPOND TO WARNING ALERTS THAT ONE OF TWO HARD DRIVES HAS FAILED; 3) USER FAILED TO PERFORM PERIODIC TESTING AND MAINTENANCE OF HARD DRIVE; 4) CRITICALLY ILL PATIENT SUSTAINS SUDDEN DETERIORATION SIMULTANEOUSLY AS THE OCCURRENCE OF A FAILURE OF THE SECOND (REDUNDANT) HARD DRIVE; 5) CAREGIVERS ARE UNAWARE OF TRIGGERING OF ALARMS ON BEDSIDE MONITORS OR HAVE DELAYED AWARENESS. THE RISK LEVEL IS DETERMINED TO BE MEDIUM.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) WAS SHUT DOWN BECAUSE OF A POWER OUTAGE AT THE HOSPITAL. UPON BOOTING UP, THE CNS HAS A "MONITOR NETWORK SERVICE DISCONNECTED" ERROR MESSAGE. THE CNS WAS BEING USED TO MONITOR PATIENTS AT THE TIME OF THE INCIDENT. UPON FURTHER TROUBLESHOOTING, THE CUSTOMER DETERMINED THE DEVICE EXPERIENCED A HARD DRIVE FAILURE. SERVICE REQUESTED/PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: WHEN A CNS IS UNEXPECTEDLY SHUT DOWN DURING OPERATION, WITHOUT GOING THROUGH THE PROPER SHUTDOWN SEQUENCE, IT COULD CAUSE A HARD DRIVE FAILURE. THERE WAS A POWER OUTAGE AT THE FACILITY. ONE OF THE RAID HARD DRIVES FAILED DUE TO THE IMPROPER SHUTDOWN SEQUENCE, AS A DIRECT RESULT OF THE POWER OUTAGE. THIS IS AN ENVIRONMENTAL ISSUE. THE DEVICE IS DESIGNED WITH A REDUNDANT ARRAY OF TWO HARD DISKS. WHEN ONE HARD DISK FAILS, THE OTHER CAN TAKE OVER. THE MANUFACTURER PROVIDED ALL SITES WITH ".BAT" FILE PATCH WHICH HELPS RECOGNIZE HARD DISK FAILURE AND PROVIDES A WARNING MESSAGE WHEN A HARD DRIVE BEGINS TO FAIL. THE MANUFACTURER ALSO UPDATED DEVICE MANUFACTURING PROCESS TO INCORPORATE THE ".BAT" FILE FUNCTION. LABELING AND OPERATOR'S MANUAL FOR VARIOUS GENERATIONS OF THIS DEVICE RECOMMEND PERIODIC MAINTENANCE OR REPLACEMENT OF HARD DISK DRIVES. THERE IS LOW LIKELIHOOD OF RISKS ASSOCIATED WITH THE USE OF DEFECTIVE DEVICE. IN ORDER FOR THE HARD DISK DRIVE TO CAUSE ADVERSE HEALTH CONSEQUENCES, AN IMPROBABLE SEQUENCE OF USER ERROR AND OTHER EVENTS WOULD ALL NEED TO OCCUR: 1) USER DECLINED TO PERMIT INSTALLATION OF SOFTWARE PATCH; 2) USER FAILS TO RESPOND TO WARNING ALERTS THAT ONE OF TWO HARD DRIVES HAS FAILED; 3) USER FAILED TO PERFORM PERIODIC TESTING AND MAINTENANCE OF HARD DRIVE; 4) CRITICALLY ILL PATIENT SUSTAINS SUDDEN DETERIORATION SIMULTANEOUSLY AS THE OCCURRENCE OF A FAILURE OF THE SECOND (REDUNDANT) HARD DRIVE; 5) CAREGIVERS ARE UNAWARE OF TRIGGERING OF ALARMS ON BEDSIDE MONITORS OR HAVE DELAYED AWARENESS. THE RISK LEVEL IS DETERMINED TO BE MEDIUM. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. CORRECTED INFORMATION: B4 DATE OF THIS REPORT: CORRECTED THE DATE FROM 04/05/2021 TO 05/05/2021.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN DUE TO A POWER OUTAGE AT THE HOSPITAL. UPON BOOTUP, THE CNS SHOWED A "MONITOR NETWORK SERVICE DISCONNECT" ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN DUE TO A POWER OUTAGE AT THE HOSPITAL. UPON BOOTUP, THE CNS SHOWED A "MONITOR NETWORK SERVICE DISCONNECT" ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN DUE TO A POWER OUTAGE AT THE HOSPITAL. UPON BOOTUP, THE CNS SHOWED A "MONITOR NETWORK SERVICE DISCONNECT" ERROR MESSAGE. DURING TROUBLESHOOTING THE CUSTOMER LATER REPORTED THEY ALSO GOT A "HDD PORT 1 ERROR" MESSAGE. 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.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN DUE TO A POWER OUTAGE AT THE HOSPITAL. UPON BOOTUP, THE CNS SHOWED A "MONITOR NETWORK SERVICE DISCONNECT" ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104681 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1