BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 11290312 · Received February 6, 2021

    Report

    Report Number
    8030229-2021-00052
    Event Type
    Malfunction
    Date Received
    February 6, 2021
    Date of Event
    January 7, 2021
    Report Date
    April 12, 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
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AFTER A POWER SURGE, THE CENTRAL NURSE'S STATION (CNS) WAS STUCK AT THE "CNS-6000, PLEASE WAIT" SCREEN. THE UPS CONNECTED TO THIS CNS HAD FAILED, CAUSING THE CNS SHUT DOWN UNEXPECTEDLY. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) HAD THEM POWER OFF THE CNS, REMOVE THE SECONDARY HDD, AND THEN POWER IT BACK ON WITH JUST THE PRIMARY HDD INSTALLED. THE ISSUE DID NOT RESOLVE, SO NK TS HAD THEM POWER OFF THE CNS, REMOVE THE PRIMARY HDD COMPLETELY FROM THE CNS, INSTALL THE SECONDARY HDD INTO PORT 0, AND THEN BOOT THE CNS WITH JUST THE SECONDARY HDD. THIS RESOLVED THE ISSUE. TECH SUPPORT HAD HIM PUT THE OTHER HDD BACK INTO THE CNS, AND THEY CONFIRMED THAT BOTH HDDS WERE FUNCTIONAL. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE ABRUPT POWER LOSS LIKELY CAUSED SOFTWARE CORRUPTION ON THE PRIMARY HARD DRIVE. THE SECONDARY RAID HARD DRIVE WAS NOT AFFECTED. ONCE THE HARD DRIVES WERE SWAPPED, THE RAID REBUILDING PROCESS BEGUN TO REPAIR THE CORRUPTED HARD DRIVE. THE EVENT DID NOT DAMAGE THE PHYSICAL HARDWARE OF THE HDD. HARD DRIVES ARE RECOMMENDED TO BE REPLACED EVERY TWO YEARS OR 20,000 HOURS OF USE. THE BOOT UP FAILURE OCCURRED ROUGHLY SIX YEARS AFTER IT WAS FIRST PUT INTO USE. ALTHOUGH POSSIBLE, IT IS UNLIKELY THAT NATURAL HARD DRIVE FAILURE COINCIDED WITH THE POWER SURGE. IT LEAVES THE PROBABLE CAUSE OF POWER SURGE INDUCING THE SOFTWARE CORRUPTION. SERVICE HISTORY FOR THIS SERIAL NUMBER SHOWS THIS IS AN ISOLATED INCIDENT. THE CNS DEVICE REQUIRES REGULAR MAINTENANCE, AS OUTLINED IN THE OPERATOR'S MANUAL. WHEN STORED FOR AN EXTENDED PERIOD, OPERATION CHECKS SHOULD BE PERFORMED. IN SHORT, THE SYMPTOMS OF A DEVICE NOT BEING ABLE TO BOOT UP ARE RELATED TO ITS INTERNAL HARD DRIVES AND/OR ENVIRONMENTAL FACTORS SUCH AS ADEQUATE POWER SUPPLY. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES H10 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AFTER A POWER SURGE, THE CENTRAL NURSE'S STATION (CNS) WAS STUCK AT THE "CNS-6000, PLEASE WAIT" SCREEN. THE UPS CONNECTED TO THIS CNS HAD FAILED, CAUSING THE CNS SHUT DOWN UNEXPECTEDLY. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD A POWER SURGE, AND THE CENTRAL NURSE'S STATION (CNS) WAS STUCK AT THE "CNS-6000, PLEASE WAIT" SCREEN. THEY STATED THAT THE UPS CONNECTED TO THIS CNS FAILED, WHICH IS WHY THE CNS SHUT OFF UNEXPECTEDLY. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) HAD THEM POWER OFF THE CNS, AND THEN REMOVE THE SECONDARY HDD, AND POWER IT BACK ON WITH JUST THE PRIMARY INSTALLED. THE CNS STILL GOT STUCK AT THE SAME SCREEN, SO TECH SUPPORT HAD THEM POWER OFF THE CNS, REMOVE THE PRIMARY HDD COMPLETELY FROM THE CNS, TOOK THE SECONDARY HDD AND INSTALLED IT INTO PORT 0, AND BOOTED THE CNS UP WITH JUST THE SECONDARY HDD. THE CNS GOT PAST THE SCREEN AND LOADED THE SOFTWARE WHERE HE COULD SEE ALL HIS PATIENTS. TECH SUPPORT HAD HIM PUT THE OTHER HDD BACK INTO THE CNS, AND THEY CONFIRMED THAT BOTH HDD'S ARE FUNCTIONAL. THE RAID DRIVES ARE WORKING AS INTENDED, AND THERE ARE NO HDD FAILURES AT THIS TIME. WALKED THEM THROUGH SWAPPING HDDS TO GET THE CNS PAST THE SYSTEM SETUP SCREEN. ISSUE RESOLVED. 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 THEY HAD A POWER SURGE, AND THE CENTRAL NURSE'S STATION (CNS) WAS STUCK AT THE "CNS-6000, PLEASE WAIT" SCREEN. THEY STATED THAT THE UPS CONNECTED TO THIS CNS FAILED, WHICH IS WHY THE CNS SHUT OFF UNEXPECTEDLY. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) HAD THEM POWER OFF THE CNS, AND THEN REMOVE THE SECONDARY HDD, AND POWER IT BACK ON WITH JUST THE PRIMARY INSTALLED. THE CNS STILL GOT STUCK AT THE SAME SCREEN, SO TECH SUPPORT HAD THEM POWER OFF THE CNS, REMOVE THE PRIMARY HDD COMPLETELY FROM THE CNS, TOOK THE SECONDARY HDD AND INSTALLED IT INTO PORT 0, AND BOOTED THE CNS UP WITH JUST THE SECONDARY HDD. THE CNS GOT PAST THE SCREEN AND LOADED THE SOFTWARE WHERE HE COULD SEE ALL HIS PATIENTS. TECH SUPPORT HAD HIM PUT THE OTHER HDD BACK INTO THE CNS, AND THEY CONFIRMED THAT BOTH HDD'S ARE FUNCTIONAL. THE RAID DRIVES ARE WORKING AS INTENDED, AND THERE ARE NO HDD FAILURES AT THIS TIME. WALKED THEM THROUGH SWAPPING HDDS TO GET THE CNS PAST THE SYSTEM SETUP SCREEN. ISSUE RESOLVED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186977 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown