BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 13057101 · Received December 21, 2021

    Report

    Report Number
    8030229-2021-02251
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 22, 2021
    Report Date
    August 28, 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
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING AN "HDD 2 ERROR" MESSAGE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: PER TN-1270 FOR PU-621R AND PU-681R, THE HDD PORT ERROR MESSAGE ON THE CNS OCCURS WHEN THE OPERATION HOURS OF THE HDD EXCEED 20,000 HOURS. AN HDD PORT ERROR MESSAGE 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 REDUNDANT ARRAY OF INDEPENDENT DISKS (RAID), SO THAT IF ONE HDD FAILS, ANOTHER HDD CAN TAKE OVER. THE MANUFACTURER ALSO PROVIDED ALL SITES WITH A ".BAT" FILE SOFTWARE PATCH WHICH HELPS RECOGNIZE HARD DISK DRIVE FAILURES AND PROVIDES A WARNING MESSAGE WHEN A HARD DRIVE BEGINS TO FAIL. THE MANUFACTURING PROCESS WAS ALSO UPDATED TO INCORPORATE THE ".BAT" FILE FUNCTION. THE OPERATOR'S MANUAL, AS WELL AS LABELING FOR VARIOUS GENERATIONS OF THE CNS RECOMMEND PERIODIC MAINTENANCE OR REPLACEMENT OF HARD DISK DRIVES. HDD PORT ERROR MESSAGES ARE NOT AN INDICATION OF DEVICE FAILURE. ATTEMPT #1 12/08/2021 CALLED CUSTOMER VIA THE PROVIDED TELEPHONE NUMNER FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 12/12/2021 CALLED CUSTOMER VIA THE PROVIDED TELEPHONE NUMBER FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 12/21/2021 CALLED CUSTOMER VIA THE PROVIDED TELEPHONE NUMNER FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. 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) IS DISPLAYING AN "HDD 2 ERROR". NO HARM OR INJURY WAS REPORTED. THEY WILL BE SENDING THIS UNIT IN FOR AN EXCHANGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS DISPLAYING AN "HDD 2 ERROR" MESSAGE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949637 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown