BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 10240137 · Received July 7, 2020

    Report

    Report Number
    8030229-2020-00363
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 16, 2020
    Report Date
    January 19, 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
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) EXPERIENCED A HARD DISC DRIVE (HDD) FAILURE. THE CNS ALSO DISPLAYED AN "HDD PORT 2 ERROR" CODE DURING PATIENT MONITORING. NO PATIENT HARM WAS REPORTED. 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. THE OVERALL RISK RATING OF THE EVENT IS LOW. NO CORRECTIVE ACTION WOULD BE PERFORMED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) EXPERIENCED A HARD DISC DRIVE (HDD) FAILURE. THE CNS ALSO DISPLAYED AN "HDD PORT 2 ERROR" CODE DURING PATIENT MONITORING. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) EXPERIENCED A HDD FAILURE. THE CUSTOMER ALSO REPORTED THAT THEIR CNS STARTED DISPLAYING AN "HDD PORT 2 ERROR" CODE DURING PATIENT MONITORING. NO HARM OR INJURY 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR CENTRAL NURSE'S STATION (CNS) EXPERIENCED A HDD FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702385 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown