BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 9366097 · Received November 22, 2019

    Report

    Report Number
    8030229-2019-00667
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 25, 2019
    Report Date
    September 20, 2021
    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
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT MULTIPLE CENTRAL NURSE'S STATION'S (CNS) EXPERIENCED COMMUNICATION LOSS. THE CUSTOMER ALSO REPORTED THAT WHEN THEY RESTARTED THE UNITS, THEY ONLY WORKED FOR ABOUT A MINUTE OR TWO BEFORE THEY WENT BACK INTO COMMUNICATION LOSS. THE UNITS WERE MONITORING A VARIETY OF TRANSMITTERS AND BEDSIDE MONITORS (BSM) AT THE TIME. THE ONLY WAY THE CUSTOMER COULD GET THE UNITS TO WORK AGAIN WAS TO RESTART THE NETKONNECT OR THE ECG SERVER. NK TS IS SUSPECTING THAT THEIR MEDIA CONVERTER HAD FAILED AND PROVIDED THE PART NUMBER FOR A REPLACEMENT, BUT IT IS UNCLEAR WHETHER THEY PURCHASED IT. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: TROUBLESHOOTING. INVESTIGATION SUMMARY: THE OVERALL RISK OF THIS EVENT IS DETERMINED TO BE MEDIUM. THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION AND FUNCTIONAL ANALYSIS. THE CUSTOMER REPORTED THAT REBOOTING THE SERVER WOULD TEMPORARILY RESOLVE THE ISSUE. WITH THIS INFORMATION, THE CAUSE OF THE COMM LOSS IS MOST LIKELY LINKED TO THE SERVER. SERVER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER HAD STATED THAT THE SERVERS WERE OLD. AS SUCH, THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS SERVER MALFUNCTION DUE TO WEAR AND TEAR. HOWEVER, AS FURTHER ANALYSIS COULD NOT BE PERFORMED ON THE SYSTEM, ROOT CAUSE CANNOT BE DETERMINED. AS THIS ISSUE HAS AN OVERALL RISK SCORE OF MEDIUM, A CAPA IS NOT REQUIRED PER CORRECTIVE ACTION AND PREVENTIVE ACTION PROCESS, SOP07-003. SINCE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CAPA IS INITIATED. WITHOUT A ROOT CAUSE, THE COUNTER MEASURE TO PREVENT RECURRENCE CANNOT BE PERFORMED. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: D4 LOT # & EXPIRATION DATE. D6A & D6B. D7B. F1 - F14. G4 DEVICE BLA NUMBER. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: MULTIPLE CNS'S: MODEL #: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.). DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI.. VARIETY OF TRANSMITTERS: MODEL #: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.). DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. VARIETY OF BEDSIDE MONITORS: MODEL #: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.) DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. 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 CUSTOMER REPORTED THAT MULTIPLE CENTRAL NURSE'S STATION'S (CNS) WERE EXPERIENCING COMMUNICATION LOSS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT MULTIPLE CENTRAL NURSE'S STATION'S (CNS) EXPERIENCED COMMUNICATION LOSS. THE CUSTOMER ALSO REPORTED THAT WHEN THEY RESTARTED THE CNS'S, THEY ONLY WORKED FOR ABOUT A MINUTE OR TWO BEFORE THEY WENT BACK INTO COMMUNICATION LOSS. THE CNS'S WERE MONITORING A VARIETY OF TRANSMITTERS AND BEDSIDE MONITORS (BSM) AT THE TIME. THE ONLY WAY THE CUSTOMER COULD GET THE CNS'S TO WORK AGAIN WAS TO RESTART THE NETKONNECT OR THE ECG SERVER. NK TS IS SUSPECTING THAT THEIR MEDIA CONVERTER HAS FAILED AND WILL BE SENDING A REPLACEMENT UNIT TO THE CUSTOMER IN AN ATTEMPT TO MITIGATE THIS ISSUE. THERE WAS NO HARM OR INJURY 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 MODEL INFORMATION: THE FOLLOWING CONCOMITANT MEDICAL PRODUCTS WERE USED IN CONJUNCTION WITH THE CNS. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: MULTIPLE CNS'S: MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NI. (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.), DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI. VARIETY OF TRANSMITTERS: MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NI. (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.), DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI. VARIETY OF BEDSIDE MONITORS: MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NI. (NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN.), DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MULTIPLE CENTRAL NURSE'S STATION'S (CNS) WERE EXPERIENCING COMMUNICATION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157814 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A NA 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1 MULTIPLE CNS'S| MULTIPLE CNS'S| VARIETY OF BEDSIDE MONITORS| VARIETY OF BEDSIDE MONITORS| VARIETY OF TRANSMITTERS| VARIETY OF TRANSMITTERS