BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9753082 · Received February 26, 2020

    Report

    Report Number
    8030229-2020-00109
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 7, 2020
    Report Date
    October 4, 2022
    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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) DISPLAYED AN "HDD PORT 1 ERROR" MESSAGE WHILE MONITORING PATIENTS. NK TS ADVISED THE CUSTOMER TO SHUT DOWN THE CNS AND REMOVE BOTH DRIVES, REPLACE THE PORT 0 DRIVE WITH PORT 1 DRIVE, AND THEN BOOT THE CNS BACK UP WITH THE SECOND HARD DRIVE OUT, WHICH RESOLVED THE ISSUE. THE CUSTOMER WILL BE RECEIVING A NEW HARD DRIVE IN ORDER TO MITIGATE THIS MATTER. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: PER TN-1270 FOR PU-621R AND PU-681R, HDD PORT ERROR ALARM ON THE CNS OCCURS WHEN THE USED HOURS OF THE HDD HAD EXCEEDED 20,000 HRS. HDD PORT ERROR PROMPTS THE USER TO CHECK THE CONDITION OF THE HDDS WHEN IT HAS EXCEEDED 20,000 HOURS OF RUNTIME. USERS MAY REPLACE THE HDDS OR MAY CONTINUE TO USE THE HDD AFTER THE INSPECTION OF THE CONDITION OF THE HDD. FAILURE TO REPLACE THE HDD OR INSPECT THE HDD MAY LEAD TO HDD FAILURE. TO MITIGATE THE RISKS FROM HDD FAILURES, THE CNS IS DESIGNED WITH RAID (REDUNDANT ARRAY OF INDEPENDENT DISKS), SO THAT IF ONE HDD FAILS, ANOTHER HDD CAN TAKE OVER. THE MANUFACTURER ALSO 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 AND HAD ALSO UPDATED DEVICE MANUFACTURING PROCESS TO INCORPORATE THE ".BAT" FILE FUNCTION. LABELING AND OPERATOR'S MANUAL FOR VARIOUS GENERATIONS OF THE CNS RECOMMEND PERIODIC MAINTENANCE OR REPLACEMENT OF HARD DISK DRIVES. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D8 WAS THIS DEVICE SERVICED BY A THIRD PARTY? 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 CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) DISPLAYED AN "HDD PORT 1 ERROR" MESSAGE WHILE MONITORING PATIENTS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION DISPLAYED "HDD PORT 1 ERROR" WHILE MONITORING PATIENTS. NK TS ADVISED THE CUSTOMER TO SHUT DOWN THE CNS AND REMOVE BOTH DRIVES. NK TS ALSO ADVISED THE CUSTOMER TO REPLACE THE PORT 0 DRIVE WITH PORT 1 DRIVE, AND THEN BOOT BACK UP WITH THE SECOND HARD DRIVE OUT, WHICH RESOLVED THE ISSUE. THE CUSTOMER WILL BE RECEIVING A NEW HARD DRIVE IN ORDER TO MITIGATE THIS MATTER. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: CONCOMITANT MEDICAL PRODUCTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION DISPLAYED "HDD PORT 1 ERROR" WHILE MONITORING PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217886 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown