BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 20756937 · Received November 22, 2024

    Report

    Report Number
    8030229-2024-04546
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 24, 2024
    Report Date
    February 5, 2025
    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
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT MONITORS WERE DROPPING OFF THE CENTRAL NURSES STATION (CNS) (PU-681RA / SN: (B)(6) FOR 10-15 SECONDS AND WOULD LIKE NK CITS TO CHECK THE NETWORK. CITS SPOKE TO THE BME, WHICH EXPLAINED THE TILES ON THE CNS WENT BLANK AND CAME BACK AFTER 20-25 SECONDS, AND THEY DID NOT SEE A COMM LOSS ERROR MESSAGE. CITS RECOMMENDED THE BME SEND THE CNS LOGS TO NKC FOR REVIEW. NO PATIENT HARM 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: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: SERVER MODEL #:A/PWREDGE-R640 - DELL SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NA UNIQUE IDENTIFIER (UDI) #: NA RETURNED TO NIHON KOHDEN: NA.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT MONITORS WERE DROPPING OFF THE CENTRAL NURSES STATION (CNS) (PU-681RA / SN: (B)(6) FOR 10-15 SECONDS AND WOULD LIKE NK CITS TO CHECK THE NETWORK. CITS SPOKE TO THE BME, WHICH EXPLAINED THE TILES ON THE CNS WENT BLANK AND CAME BACK AFTER 20-25 SECONDS, AND THEY DID NOT SEE A COMM LOSS ERROR MESSAGE. CITS RECOMMENDED THE BME SEND THE CNS LOGS TO NKC FOR REVIEW. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED, NO PATIENT HARM, NO INJURY, NOR ANY ADVERSE EVENT, DUE TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE CNS WAS RETURNED TO NK FOR AN EVALUATION/REPAIR ON TICKET 223088. THE REPORTED ISSUE COULD NOT BE DUPLICATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, UPON EVALUATION FROM THE REPAIR CENTER THEY FOUND THE CNS (TICKET 223088) TO GET STUCK IN A BLUE SCREEN. THE UNIT REQUIRED THE HDDS TO BE RE-IMAGED, INITIALIZE THE SYSTEM, CALIBRATE THE TOUCH SCREEN AND CHECK THE COMMUNICATION WITH THE BESIDE MONITORS. THE UNIT WAS REPAIRED AND SHIPPED BACK TO THE CUSTOMER. ADDITIONALLY, THE SWITCH IS PENDING REPLACEMENT. WE HAVE ALSO IDENTIFIED SEVERAL POTENTIAL CAUSES OF COMMUNICATION RELATED ISSUES, WHICH ARE NOT LIMITED TO, AND EXPLAINED IN FURTHER DETAIL BELOW: COMMUNICATION LOSS IS AN ERROR MESSAGE DISPLAYED ON INDIVIDUAL BED TILES ON THE CNS THAT ALERTS CLINICIANS THAT THE CONNECTION BETWEEN THE CNS AND THE DEVICE IT IS MONITORING HAS BEEN LOST. NETWORK ISSUES: THE ACCESS POINTS IN THE AREA WHERE THE ISSUE IS OCCURRING MAY HAVE BEEN LOADED WITH TRAFFIC OR HAVE A BAD CONNECTION, OR THEY MAY HAVE EXPERIENCED INTERFERENCE ON THE AREA CAUSING THE CONNECTIVITY ISSUES. IF TRANSMITTERS ARE ASSIGNED TO ADJACENT OR DUPLICATE CHANNELS OF THE NETWORK, THERE WOULD BE RADIO WAVE INTERFERENCE WHICH MAY CAUSE COMMUNICATION LOSS. OTHER DEVICES ON THE HOSPITAL FACILITY MAY ALSO CAUSE INTERFERENCE WHICH COULD ALSO CAUSE COMMUNICATION LOSS. IF THE NETWORK HOST TABLE BECOMES UNBALANCED, COMM LOSS COULD OCCUR. IF THE TELEMETRY DEVICE IS APPROACHING THE RANGE BOUNDARIES OR OUT OF RANGE OF AN ACCESS POINT, IT MAY EXPERIENCE COMM LOSS. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE (MODEL: A/PWREDGE- R640, SERIAL NUMBER: (B)(6) DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: SERVER MODEL #: A/PWREDGE-R640 - DELL SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: NA UNIQUE IDENTIFIER (UDI) #: NA RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT MONITORS WERE DROPPING OFF THE CENTRAL NURSES STATION (CNS) FOR 10-15 SECONDS AND WOULD LIKE NK CITS TO CHECK THE NETWORK. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT MONITORS WERE DROPPING OFF THE CENTRAL NURSES STATION (CNS) FOR 10-15 SECONDS AND WOULD LIKE NK CITS TO CHECK THE NETWORK. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599985 PU-681RA CENTRAL MONITOR SYSTEM (CNS-6801A) MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SERVER| SERVER