BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 13015058 · Received December 15, 2021

    Report

    Report Number
    8030229-2021-02116
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 17, 2021
    Report Date
    May 23, 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
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATIONS (CNSS) AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNSS), WERE SHOWING COMM LOSS FOR ALL GZ TELEMETRY TRANSMITTERS. BY THE TIME THE BME CALLED IN THE TICKET, MOST OF THE GZS WERE BACK UP, EXCEPT 4 UNITS. THEY LATER REPORTED THAT AFTER REBOOTING THESE GZS, THEY CAME OUT OF COMM LOSS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: ASSISTANCE FOR TROUBLESHOOTING THE REMAINING FOUR GZ DEVICES WAS REQUESTED. THE ISSUE WAS INTERMITTENT. THE ISSUE CONTINUED TO MAY 2022. ON 5/9/2022 WHEN THE CONDITIONS WERE RIGHT, THE NKA NETWORK ENGINEER IDENTIFIED TAKEOVERS AT THE HOST TABLE. THE CUSTOMER WAS INSTRUCTED TO REBOOT THE BEDSIDE DEVICE IN QUESTION THAT WAS RESPONSIBLE FOR THE TAKEOVER. REMOVING THE BEDSIDE TAKEOVER DID NOT RESOLVE THE INTERMITTENT COMMUNICATION LOSS. THE INTERMITTENT COMMUNICATION LOSS WAS ISOLATED TO ONE DEPARTMENT AND OCCURRED AT REGULAR INTERVALS: TWICE EACH DAY 8-10AM AND 1-3PM AND LASTED APPROXIMATELY 5 MINUTES. THE NEXT STEP WAS TO RESTART THE UNIFIED GATEWAY GZ WIRELESS SERVICE. THIS DID NOT RESOLVE THE COMMUNICATION LOSS. FURTHER INFORMATION WAS NOT MADE AVAILABLE. THE SERVICE HISTORY FOR THIS FACILITY WAS REVIEWED TO LOOK FOR RESOLUTION. THERE WERE NO OTHER REPORTS FOR SYSTEM WIDE GZ COMMUNICATION LOSS REPORTED AFTER JUNE 2022, THE LAST DATE ON THE CURRENT TICKET. ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A SPECIFIC DEVICE MALFUNCTION. THE REGULARITY NATURE OF THE INCIDENTS INDICATES NETWORKING OR ENVIRONMENTAL FACTORS. SINCE THE CUSTOMER HAS NOT REPORTED FURTHER EVENTS, IT IS PRESUMED THAT THE ISSUE WAS RESOLVED AND WITHOUT ANY REPORTED DEVICE FAILURE. THERE IS NO RECURRENCE HISTORY FOR THIS DEVICE. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT #1 11/19/2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 11/30/2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 12/06/2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT AND DEVICE INFORMATION AS REQUESTED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: MULTIPLE GZ TRANSMITTERS: MODEL #: NI. SERIAL #: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATIONS (CNSS) AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNSS), WERE SHOWING COMMUNICATION LOSS FOR THE ALL THE GZ TELEMETRY TRANSMITTERS. BY THE TIME THE BIOMED CALLED IN THE TICKET, MOST OF THE GZS WERE BACK UP, EXCEPT FOR THE 4 UNITS THAT REMAINED IN COMMUNICATION LOSS. THEY LATER STATED THAT AFTER REBOOTING THESE GZS, THEY CAME BACK OUT OF COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATIONS (CNSS) AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNSS), WERE SHOWING COMM LOSS FOR ALL GZ TELEMETRY TRANSMITTERS. BY THE TIME THE BME CALLED IN THE TICKET, MOST OF THE GZS WERE BACK UP, EXCEPT 4 UNITS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911136 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GZ TELEMETRY TRANSMITTER(S)| GZ TELEMETRY TRANSMITTERS