BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 10564814 · Received September 21, 2020

    Report

    Report Number
    8030229-2020-00552
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 22, 2020
    Report Date
    January 25, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATIONS (CNS) AND THE REMOTE NETWORK STATIONS (RNS) WENT DOWN DUE TO A POWER ISSUE WITH THE SERVERS. THEY CORRECTED THE POWER ISSUE, AND THE CNSS CAME BACK UP NORMALLY, BUT THE RNSS WERE IN COMM LOSS. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) RESTARTED THE UNIFIED GATEWAY (UG) SERVICE, WHICH RESOLVED THE ISSUE WITH THE RNSS. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE ISSUE WAS RESOLVED WHEN CITS REMOTED INTO THE SYSTEM AND RESET THE UG SERVICE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. AN UNGRACEFUL EXIT DUE TO A POWER OUTAGE RESULTED IN NETWORK SETTINGS DEFAULTING TO THE FACTORY SETTINGS, WHICH WERE RESOLVED WITH THE UG SERVICE REBOOT.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THEY HAD A POWER ISSUE WITH THE SERVERS AND THE CENTRAL NURSE'S STATIONS (CNS) AND THE REMOTE NETWORK STATIONS (RNS) WENT DOWN. THEY CORRECTED THE ISSUE WITH THE POWER AND THE CNSS CAME BACK UP NORMALLY, BUT THE RNSS ALL SHOWED AS COMMUNICATION LOSS. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) RESTARTED THE UNIFIED GATEWAY SERVICE, AND THE RNSS WERE NOW ABLE TO MONITOR PATIENTS. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THEY HAD A POWER ISSUE WITH THE SERVERS, THE CENTRAL NURSE'S STATIONS (CNS), AND THE REMOTE NETWORK STATIONS (RNS) WENT DOWN. THEY CORRECTED THE ISSUE WITH THE POWER, AND THE CNSS CAME BACK UP NORMALLY, BUT THE RNSS ALL SHOWED AS COMMUNICATION LOSS. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) RESTARTED THE UNIFIED GATEWAY SERVICE, AND THE RNSS WERE NOW ABLE TO MONITOR PATIENTS. 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. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CNS. REMOTE NETWORK STATION: MODEL: RNS-6803, SN: (B)(4).

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THEY HAD A POWER ISSUE WITH THE SERVERS, THE CENTRAL NURSE'S STATIONS (CNS), AND THE REMOTE NETWORK STATIONS (RNS) WENT DOWN. THEY CORRECTED THE ISSUE WITH THE POWER, AND THE CNSS CAME BACK UP NORMALLY, BUT THE RNSS ALL SHOWED AS COMMUNICATION LOSS. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) RESTARTED THE UNIFIED GATEWAY SERVICE, AND THE RNSS WERE NOW ABLE TO MONITOR PATIENTS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028732 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RNS-6803 SN (B)(6)| RNS-6803 SN (B)(6)