BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 10075746 · Received May 20, 2020

    Report

    Report Number
    8030229-2020-00277
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 27, 2020
    Report Date
    May 12, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON 04/27/2020, THE CUSTOMER AT (B)(6) MEDICAL CENTER, INC. REPORTED THAT ALL RNS (A/RNS-9703-024, SN #: (B)(6)) DEVICES WERE DOWN (IN COMM LOSS), AND ABOUT HALF OF THE TELEMETRY DEVICES AT ALL CENTRAL NURSE'S STATIONS (CNS) WERE IN COMM LOSS. SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING. SERVICE PERFORMED: SERVICE PERFORMED: NK TS VERIFIED THE HOST SERVER AND FOUND THAT THE .30 SEGMENT SERVER WAS HAVING PROBLEMS AT 03:17AM AND THEN CAME BACK AT 03:44. NK TS REPLACED BOTH THE 10 SEGMENT AND 20 SEGMENT HOST SERVERS TO RESOLVE THE ISSUE. INVESTIGATION SUMMARY: THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE DUE TO BAD SEGMENTS/HOST SERVERS. THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM. THE ISSUE WAS NOT SUSPECTED TO BE CAUSED BY A MALFUNCTION OR DEVIATION OF FUNCTIONALITY OF THE DEVICE FROM THE SPECIFIED FUNCTIONALITY. ALSO, COMMUNICATION LOSS AT THE CNS CAN IMPACT PATIENT MONITORING ON TELEMETRY DEVICES, HOWEVER PATIENTS NOT ON TELEMETRY DEVICES WERE BEING MONITORED ON BSMS WITHOUT ANY ISSUE. REVIEW OF THE DEVICE HISTORY FOUND NO SIMILAR INCIDENTS OF COMMUNICATION LOSS BEFORE OR AFTER THIS INCIDENT WAS REPORTED. THEREFORE, A CAPA WAS NOT INITIATED. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. ATTEMPT # 1: 04/27/2020 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 04/28/2020 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 3: 04/29/2020 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: REMOTE NETWORK STATIONS: MODEL #: RNS-9703-024; SERIAL #: (B)(6); DEVICE MANUFACTURER DATA: NI; UNIQUE IDENTIFIER (UDI) #: NI; RETURNED TO NIHON KOHDEN: NI. TELEMETRY TRANSMITTERS: MODEL #: RNI; SERIAL #: NI; DEVICE MANUFACTURER DATA: NI; UNIQUE IDENTIFIER (UDI) #: NI; RETURNED TO NIHON KOHDEN: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE IN COMMUNICATION LOSS WITH HALF OF THE TELEMETRY TRANSMITTERS; AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNS), ARE ALL IN COMMUNICATION LOSS. THIS WAS DUE TO THE SERVERS BEING DOWN AND SERVERS WERE REPLACED. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE IN COMMUNICATION LOSS WITH HALF OF THE TELEMETRY TRANSMITTERS; AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNS), ARE ALL IN COMMUNICATION LOSS. THIS WAS DUE TO THE SERVERS BEING DOWN AND SERVERS WERE REPLACED. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: BRAND NAME, MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, AGE OF THE DEVICE, PMA / 510K NUMBER, DEVICE MANUFACTURE DATE. ADDITIONAL MODEL INFORMATION: CONCOMITANT MEDICAL DEVICE INFORMATION: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS, BUT THE MODEL AND SERIAL NUMBER INFORMATION FOR THE TELEMETRY TRANSMITTERS WERE NOT PROVIDED AND THEREFORE NO INFORMATION (NI) IS NOTED. REMOTE NETWORK STATION: MODEL: RNS-9703-024, SN: (B)(4). TELEMETRY TRANSMITTERS: MODEL: NI, SN: NI.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE IN COMMUNICATION LOSS WITH HALF OF THE TELEMETRY TRANSMITTERS; AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNS), ARE ALL IN COMMUNICATION LOSS. THIS WAS DUE TO THE SERVERS BEING DOWN AND SERVERS WERE REPLACED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539694 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 RNS-9703-024 SN (B)(6).| RNS-9703-024 SN (B)(6).| TELEMETRY TRANMITTERS.| TELEMETRY TRANMITTERS.