BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 12849065 · Received November 19, 2021

    Report

    Report Number
    8030229-2021-02007
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 21, 2021
    Report Date
    March 27, 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
    OH, 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) DISPLAYED A "PORT 1 ERROR" AFTER WHICH THEY DECIDED TO REBOOT THE DEVICE, BUT IT WOULD NOT BOOT INTO THE CNS SOFTWARE. THE HDD HAD FAILED ON THIS CNS, AND NEEDED TO BE REPLACED. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE HDD PORT ERROR IS AN INFORMATIONAL MESSAGE TO NOTIFY THE USER THAT THE SPECIFIC HDD HAD EXCEEDED ITS 20,000 HOURS OF RUNTIME AND SUGGESTS THE USER CONSIDER REPLACING THE HDD TO PREVENT AN HDD FAILURE. THIS MESSAGE DOES NOT HINDER OR PREVENT THE USER FROM VIEWING REAL TIME PATIENT MONITORING. IN A FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, THEY INDICATED THAT THE CNS WAS NO LONGER BOOTING INTO THE SOFTWARE. THIS ISSUE WAS RESOLVED AFTER REMOVING THE PORT 1 HDD AND REPLACING IT WITH THE PORT 0 HDD. THE DEVICE HAD BEEN SERVICE SINCE 03/27/2016. A REVIEW OF THE HISTORY OF THE SERIAL NUMBER IDENTIFIED NO SIMILAR EVENTS. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, DUE TO THE DEVICE RECEIVING THE HDD PORT 1 ERROR MESSAGE, IT IS LIKELY THAT THE HDD HAD FAILED DUE TO WEAR AND TEAR FROM NORMAL USE. USER MAY ALSO HAVE MISSED CHECKING THE CONDITION OF THE HDD WHEN THEY RECEIVED THE ERROR MESSAGE. THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. AVAILABLE INFORMATION SUGGESTS THAT THE ISSUE MAY HAVE BEEN TO WEAR AND TEAR OF THE HDD FROM NORMAL USE, AND INADEQUATE MAINTENANCE/INSPECTION OF THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAYED A "PORT 1 ERROR" AFTER WHICH THEY DECIDED TO REBOOT THE DEVICE, BUT IT WOULD NOT BOOT INTO THE CNS SOFTWARE. THE HDD FAILED ON THIS CNS AND IT NEEDS TO BE REPLACED. NO HARD OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747285 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown