BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130P

    MDR report key: 22362280 · Received June 30, 2025

    Report

    Report Number
    8030229-2025-05127
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 4, 2025
    Report Date
    September 17, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921117415
    PMA / PMN Number
    K163459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD TWO GZ TRANSMITTERS THAT WERE MONITORED ON SEPARATE G9 MONITORS THROUGH HI-Q VIEW, AND ON SEPARATE CNS DEVICES. THE VITALS FOR (B)(6) WERE SHOWN IN (B)(6) AND VICE VERSA. THEY WERE ABLE TO RESOLVE THE ISSUE BY STOPPING HI-Q VIEW MODE AND THEN RESTARTING IT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER GZ TRANSMITTER (TICKET (B)(4). THERE WAS NO PATIENT HARM 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 DEVICES WERE USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: NI (NO MODEL INFO WILL BE PROVIDED) SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: . CNS: MODEL #: NI (NO MODEL INFO WILL BE PROVIDED) SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: . GZ TRANSMITTER (IN ROOM (B)(6)): MODEL #: GZ-130PA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 01/11/2022 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: . G9 MONITOR (IN ROOM (B)(6) MODEL #: CU-192RA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 09/03/2020 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: . G9 MONITOR (IN ROOM (B)(6): MODEL #: CU-192RA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 09/07/2020 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: .

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD TWO GZ TRANSMITTERS THAT WERE MONITORED ON SEPARATE G9 MONITORS THROUGH HI-Q VIEW, AND ON SEPARATE CNS DEVICES. THE VITALS FOR ROOM (B)(4) WERE SHOWN IN ROOM (B)(4) AND VICE VERSA. THEY WERE ABLE TO RESOLVE THE ISSUE BY STOPPING HI-Q VIEW MODE AND THEN RESTARTING IT. THERE WAS NO PATIENT HARM REPORTED. INVESTIGATION SUMMARY: THE DEVICE LOGS WERE SENT IN FOR NKC INVESTIGATION. BELOW IS A LIST OF THE LOGS FROM THE TIME HIQ-VIEW WAS STARTED FOR BEDS (B)(6) ON THE RELEVANT DATE AND TIME. BEDID: H808 (S/N: (B)(6). ON (B)(6) 2025 14:30:18: SETTINGS: HIQ-VIEW START REQUEST: (ADDR: 0A671924/671924C3 / MONITOR / LOCAL). ON (B)(6) 2025 13:38:07: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671922/671922C3 / MONITOR / LOCAL). ON (B)(6) 2025 13:35:02: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671922/671922C3 / MONITOR / LOCAL). ON (B)(6) 2025 3:33:56: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671924/671924C3 / MONITOR / LOCAL). BEDID: H817 (S/N: (B)(6). ON (B)(6) 2025 14:58:24: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671922/671922C3 / MONITOR / LOCAL). ON (B)(6) 2025 14:01:52: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671924/671924C3 / MONITOR / LOCAL). ON (B)(6) 2025 9:46:39: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671922/671922C3 / MONITOR / LOCAL). IT WAS CONFIRMED THAT ON (B)(6) 2025, HIQ-VIEW WAS STARTED, SPECIFYING TELEMETRY DIFFERENT FROM THE NORMAL USAGE. THE ORIGINAL TELEMETRY IP ADDRESS WAS SPECIFIED AGAIN BETWEEN 14:30 AND 15:00 ON (B)(6), SO IT IS LIKELY THAT IT RETURNED TO NORMAL AT THIS POINT. THEREFORE, IT IS POSSIBLE THAT THERE WAS AN OPERATIONAL ERROR WHEN STARTING HIQ-VIEW. MEASURES TO PREVENT RECURRENCE WERE PROVIDED TO THE CUSTOMER: WHEN CHOOSING A BED TO START HIQ-VIEW, PLEASE BE CAREFUL TO CHOOSE THE CORRECT BED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL#: NI (NO MODEL INFO WILL BE PROVIDED), SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI)#: NI, RETURNED TO NIHON KOHDEN: NA. CNS: MODEL#: NI (NO MODEL INFO WILL BE PROVIDED), SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI)#: NI, RETURNED TO NIHON KOHDEN: NA. GZ TRANSMITTER (IN ROOM (B)(6): MODEL#: GZ-130PA, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: 01/11/2022, UNIQUE IDENTIFIER (UDI)#: (B)(4), RETURNED TO NIHON KOHDEN: NA. G9 MONITOR (IN ROOM (B)(6), MODEL#: CU-192RA, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: 09/03/2020, UNIQUE IDENTIFIER (UDI)#: (B)(4), RETURNED TO NIHON KOHDEN: NA. G9 MONITOR (IN ROOM (B)(4): MODEL#: CU-192RA, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: 09/07/2020, UNIQUE IDENTIFIER (UDI)#: (B)(4), 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? H6: EVENT PROBLEM AND EVALUATION CODES. H11: ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD TWO GZ TRANSMITTERS THAT WERE MONITORED ON SEPARATE G9 MONITORS THROUGH HI-Q VIEW, AND ON SEPARATE CNS DEVICES. THE VITALS FOR (B)(6) WERE SHOWN IN (B)(6) AND VICE VERSA. THEY WERE ABLE TO RESOLVE THE ISSUE BY STOPPING HI-Q VIEW MODE AND THEN RESTARTING IT. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAD TWO GZ TRANSMITTERS THAT WERE MONITORED ON SEPARATE G9 MONITORS THROUGH HI-Q VIEW, AND ON SEPARATE CNS DEVICES. THE VITALS FOR ROOM (B)(4) WERE SHOWN IN ROOM (B)(4) AND VICE VERSA. THEY WERE ABLE TO RESOLVE THE ISSUE BY STOPPING HI-Q VIEW MODE AND THEN RESTARTING IT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130768 GZ-130P TELEMETRY TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-130P NA 04931921117415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 2 CNS DEVICES.| 2 CNS DEVICES.| 2 G9 MONITORS.| 2 G9 MONITORS.| GZ TRANSMITTER.| GZ TRANSMITTER.