BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130P

    MDR report key: 23774620 · Received December 10, 2025

    Report

    Report Number
    8030229-2025-05901
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 30, 2025
    Report Date
    January 23, 2026
    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 THE READING DROPPED ON THIS GZ TELE THAT WAS CONNECTED TO A CU-192RA BEDSIDE MONITOR BEING MONITORED ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. BIOMED DID NOT HAVE THE PRINTOUTS. REQUEST FOR THE PRINTOUT VIA EMAIL. THE ISSUE ONLY AFFECTED THIS PATIENT. BIOMED MENTIONED THERE WAS A VFIB THAT OCCURRED BEFOREHAND AT 17:51 FOR 50 SECONDS, THE DATA WAS DROPPED AFTERWARD. MRN #: (B)(4). INVESTIGATION CONCLUSION: <DETAILED INVESTIGATION RESULTS> WE CONDUCTED A LOG INVESTIGATION. G9 LOG AROUND (B)(6) 17:52, TWO LOGS WERE OUTPUT INDICATING THE G9 HAD RECONNECTED TO THE TELEMETRY USING HIQ-VIEW, AS SHOWN BELOW. (B)(6) 2025 17:52:01: SETTINGS: HIQ-VIEW START RESULT: (SUCCESS / NONE / RESTART). (B)(6) 2025 17:52:12: SETTINGS: HIQ-VIEW START RESULT: (SUCCESS / NONE / RESTART). IF THE ABOVE MESSAGE INDICATING THE G9 HAD RECONNECTED TO THE TELEMETRY USING HIQ-VIEW IS OUTPUT, IT MEANS THAT THE G9 WAS UNABLE TO COMMUNICATE WITH THE TELEMETRY BEFORE THE MESSAGE WAS OUTPUT. UNFORTUNATELY, THE LOG DOES NOT INDICATE WHEN THE COMMUNICATION FAILURE BEGAN. IT APPEARS THAT DATA FROM THE AFOREMENTIONED PERIOD OF COMMUNICATION FAILURE IS NOT AVAILABLE. NOTE THAT HIQ-VIEW WITH THE AFFECTED GZ APPEARS TO HAVE BEEN RUNNING SINCE (B)(6) 19:07. (B)(6) 2025 19:07:53: SETTINGS: HIQ-VIEW START REQUEST: (ADDR:0A671924/671924BD / MONITOR / LOCAL) (B)(6) 2025 19:07:54: SETTINGS: HIQ-VIEW START RESULT: (SUCCESS / NONE / STARTBYLOCAL). GZ LOG: CHECKING THE GZ LOG, THE RSSI WAS BELOW 20 FROM 17:52:00 TO 17:52:27, SUGGESTING POOR SIGNAL CONDITIONS. THE RECONNECTION HISTORY WAS RECORDED IN A LOCATION THAT MATCHED THE G9 LOG. (B)(6) 2025 17:51:59 NET9 BACKFILL DISCONNECT / NO FAIL, (B)(6) 2025 17:52:00 NET9 BACKFILL RECONNECT / NO FAIL, (B)(6) 2025 17:52:10 NET9 BACKFILL DISCONNECT / NO FAIL, (B)(6) 2025 17:52:12 NET9 BACKFILL RECONNECT / NO FAIL, (B)(6) 2025 17:52:27 NET9 BACKFILL DATA TRANSFER REQUEST SEND / NO FAIL, (B)(6) 2025 17:52:27 NET9 BACKFILL FAIL / UNEXPECTED RESPONSE, THIS APPEARS TO BE WHEN THE WAVEFORM WAS INTERRUPTED. DUE TO THE BACKFILL SPECIFICATIONS, IF A NEW DISCONNECTION OCCURS AFTER RECOVERY FROM A DISCONNECTION BUT BEFORE A BACKFILL TRANSFER, THE FIRST BACKFILL IS CANCELED AND PREPARATION FOR THE SECOND DISCONNECTION BEGINS. AS A RESULT, THERE ARE MISSING WAVEFORMS FOR THE FIRST DISCONNECTION (FROM (B)(6) 2025 17:51:59). ALSO, THERE IS A LOG OF A BACKFILL FAILURE AT (B)(6) 2025 17:52:27, SO IT IS LIKELY THAT THE SECOND DISCONNECTION PERIOD (FROM (B)(6) 2025 17:52:10) WAS BLANK DUE TO A TRANSFER FAILURE. IT IS HOPED THAT IMPROVING THE WIRELESS LAN SIGNAL ENVIRONMENT WILL PREVENT THIS ISSUE FROM RECURRING. DEVICES INVOLVED: MODEL: GZ-130PA, S/N: (B)(6), SW: 02-71. MODEL: CU-192RA, S/N: (B)(6), BED ID: H824, SW: 01-38, IP: 10.103.38.96. MODEL: PU-681RA S/N: (B)(6), SW: NI, IP: NI. DATE OF INCIDENT: 11/30/2025 TIME OF INCIDENT: 17:52 ADDITIONAL DEVICE INFORMATION: CENTRAL NURSE'S STATION: MODEL: PU-681RA SN: (B)(6). BEDSIDE MONITOR: MODEL: CU-192RA, SN: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE READING DROPPED ON THIS GZ TELE THAT WAS CONNECTED TO A CU-192RA BEDSIDE MONITOR BEING MONITORED ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. BIOMED DID NOT HAVE THE PRINTOUTS. REQUEST FOR THE PRINTOUT VIA EMAIL. THE ISSUE ONLY AFFECTED THIS PATIENT. BIOMED MENTIONED THERE WAS A VFIB THAT OCCURRED BEFOREHAND AT 17:51 FOR 50 SECONDS, THE DATA WAS DROPPED AFTERWARD. MRN #: (B)(4). DEVICES INVOLVED. MODEL: GZ-130PA. S/N: (B)(6). SW: 02-71. MODEL: CU-192RA. S/N: (B)(6). BED ID: H824. SW: 01-38. IP: 10.103.38.96. MODEL: PU-681RA. S/N: (B)(6). SW: NI. IP: NI. DATE OF INCIDENT: (B)(6) 2025. TIME OF INCIDENT: 17:52. ADDITIONAL DEVICE INFORMATION: CENTRAL NURSE'S STATION. MODEL: PU-681RA. SN: (B)(6). BEDSIDE MONITOR. MODEL: CU-192RA. SN: (B)(6).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE READING DROPPED ON THIS GZ TELE THAT WAS CONNECTED TO A CU-192RA BEDSIDE MONITOR BEING MONITORED ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. BIOMED DID NOT HAVE THE PRINTOUTS. REQUEST FOR THE PRINTOUT VIA EMAIL. THE ISSUE ONLY AFFECTED THIS PATIENT. BIOMED MENTIONED THERE WAS A VFIB THAT OCCURRED BEFOREHAND AT 17:51 FOR 50 SECONDS, THE DATA WAS DROPPED AFTERWARD. MRN #: (B)(4). DEVICES INVOLVED: MODEL: GZ-130PA, S/N: (B)(6), SW: 02-71. MODEL: CU-192RA S/N: (B)(6), BED ID: H824, SW: 01-38, IP: 10.103.38.96. MODEL: PU-681RA, S/N: (B)(6), SW: NI, IP: NI. DATE OF INCIDENT: 11/30/2025, TIME OF INCIDENT: 17:52.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE READING DROPPED ON THIS GZ TELE THAT WAS CONNECTED TO A CU-192RA BEDSIDE MONITOR BEING MONITORED ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. BIOMED DID NOT HAVE THE PRINTOUTS. REQUEST FOR THE PRINTOUT VIA EMAIL. THE ISSUE ONLY AFFECTED THIS PATIENT. BIOMED MENTIONED THERE WAS A VFIB THAT OCCURRED BEFOREHAND AT 17:51 FOR 50 SECONDS, THE DATA WAS DROPPED AFTERWARD. MRN #: (B)(4). DEVICES INVOLVED. MODEL: GZ-130PA. S/N: (B)(6). SW: 02-71. MODEL: CU-192RA. S/N: (B)(6). BED ID: H824. SW: 01-38. IP: 10.103.38.96. MODEL: PU-681RA. S/N: (B)(6). SW: NI. IP: NI. DATE OF INCIDENT: (B)(6) 2025. TIME OF INCIDENT: 17:52.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772261 GZ-130P TELEMETRY TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-130P NA 04931921117415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CU-192RA SN (B)(6).| PU-681RA SN (B)(6).