BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 10525871 · Received September 11, 2020

    Report

    Report Number
    8030229-2020-00529
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 12, 2020
    Report Date
    March 1, 2023
    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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THEY HAD A POWER FAILURE, AND THE UPS CONNECTED TO THE CENTRAL NURSE'S STATION (CNS) FAILED, CAUSING THE CNS TO POWER OFF UNEXPECTEDLY. IT WOULD NOT BOOTUP PAST THE INITIAL BOOT SPLASH SCREEN. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) HAD THEM POWER THE CNS OFF, REMOVE THE PRIMARY HDD AND PUT THE SECONDARY HDD INTO THE PRIMARY PORT, THEN BOOT THE CNS UP WITH JUST ONE HDD. THE CNS BOOTED UP AND LAUNCHED INTO THE CNS SOFTWARE SUCCESSFULLY. ONCE THE SOFTWARE WAS UP AND RUNNING, NK TS HAD THEM INSERT THE OTHER HDD INTO PORT 1. THEY VERIFIED THAT BOTH HDDS WERE GOOD AND WERE REBUILDING THE RAID. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: SPONTANEOUS SHUTDOWN OR SPONTANEOUS REBOOT EVENTS ARE TRIGGERED BY EITHER A POWER LOSS OR A HARDWARE FAILURE. THE CAUSES OF EACH ARE DISCUSSED BELOW. POWER LOSS WHEN THE CNS EXPERIENCES A POWER LOSS, IT CAN BE CAUSED BY A VARIETY OF EVENTS. THESE EVENTS INCLUDE POWER OUTAGES, GENERATOR TESTS, UNINTERRUPTIBLE POWER SUPPLY (FAILURE), POWER OUTLET FAILURE. THESE ARE ENVIRONMENTAL FACTORS THAT IMPACT DEVICE FUNCTIONALITY. HARDWARE FAILURE 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, MORTARBOARD, CPU, MEMORY, ETC. MOST COMMONLY, HARD DRIVE FAILURES WILL RESULT IN SPONTANEOUS SHUTDOWN OR REBOOT. IN THIS PARTICULAR CASE, THE USER'S FACILITY EXPERIENCED A POWER BUMP WHICH CAUSED ABRUPT POWER LOSS TO THE CNS. THE ABRUPT POWER LOSS CAUSED HARD DRIVE FAILURE, RESULTING IN THE FAILURE TO REBOOT BACK INTO THE CNS APPLICATION.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER FAILURE, AND THE UPS CONNECTED TO THE CENTRAL NURSE'S STATION (CNS) FAILED, CAUSING THE CNS TO POWER OFF UNEXPECTEDLY. IT WOULD NOT BOOTUP PAST THE INITIAL BOOT SPLASH SCREEN.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER FAILURE, AND THERE WAS A UPS CONNECTED TO THE CENTRAL NURSE'S STATION (CNS), BUT IT FAILED AND CAUSED THE CNS TO POWER OFF UNEXPECTEDLY. THEN THEY TRIED TO POWER ON THE CNS, BUT IT WOULD NOT GET PAST THE INITIAL BOOT SPLASH SCREEN. NIHON KOHDEN TECHNICAL SUPPORT HAD THEM POWER THE CNS OFF, REMOVE THE PRIMARY HDD AND PUT THE SECONDARY HDD INTO THE PRIMARY PORT, AND BOOT THE CNS UP WITH JUST ONE HDD. THE CNS BOOTED UP AND LAUNCHED INTO THE SOFTWARE SUCCESSFULLY. ONCE THE SOFTWARE WAS UP AND RUNNING, TECHNICAL SUPPORT HAD THEM INSERT THE OTHER HDD INTO PORT 1. THEN THEY CHECKED THE INTEL STORAGE MATRIX, AND IT SHOWED THAT BOTH HDD'S WERE GOOD AND IT WAS REBUILDING THE RAID. NO PATIENT HARM 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS MISSING INFORMATION (MI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER FAILURE, AND THERE WAS A UPS CONNECTED TO THE CENTRAL NURSE'S STATION (CNS), BUT IT FAILED AND CAUSED THE CNS TO POWER OFF UNEXPECTEDLY. THEN THEY TRIED TO POWER ON THE CNS, BUT IT WOULD NOT GET PAST THE INITIAL BOOT SPLASH SCREEN. NIHON KOHDEN TECHNICAL SUPPORT HAD THEM POWER THE CNS OFF, REMOVE THE PRIMARY HDD AND PUT THE SECONDARY HDD INTO THE PRIMARY PORT, AND BOOT THE CNS UP WITH JUST ONE HDD. THE CNS BOOTED UP AND LAUNCHED INTO THE SOFTWARE SUCCESSFULLY. ONCE THE SOFTWARE WAS UP AND RUNNING, TECHNICAL SUPPORT HAD THEM INSERT THE OTHER HDD INTO PORT 1. THEN THEY CHECKED THE INTEL STORAGE MATRIX, AND IT SHOWED THAT BOTH HDD'S WERE GOOD AND IT WAS REBUILDING THE RAID. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989803 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MI.| NI.