MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120P; TELEMETRY TRANSMITTER

Model Number	GZ-120P
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse station (cns, sn: (b)(6) was not alarming audibly when the gz transmitter (sn: (b)(6) had a low battery.Not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse station (cns, sn: (b)(6) was not alarming audibly when the gz transmitter (sn: (b)(6) had a low battery.The 'change battery' option was displayed in blue with a yellow warning, but there was no accompanying sound.The issue was discovered during testing.Not in patient use.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 device was used in conjunction with the gz transmitter: central nurse's station (cns): model #: pu-621r, serial #: (b)(6), device manufacturer data: 04/23/2015, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse station (cns, sn: (b)(6) was not alarming audibly when the gz transmitter (sn: (b)(6) had a low battery.The 'change battery' option was displayed in blue with a yellow warning, but there was no accompanying sound.The issue was discovered during testing.Not in patient use.For remedial troubleshooting, nihon kohden technical support advised the bme to stop monitoring the gz through the cns and start again and disable the hi-q view option on the unit.The bme planned to keep the unit under observation and follow up with nihon kohden.Investigation summary: multiple attempts were made to collect additional information, but there has been no response from the customer.As such, a definitive root cause cannot be established.From the description of events and troubleshooting, the most likely explanation is transient software malfunction or software settings.A review of the device's complaint history by serial number reveals no comparable issues.Similarly, a review of the facility's complaint history does not reveal similar issues that would constitute a trend.Nihon kohden will continue to trend and monitor.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: central nurse's station (cns): model #: pu-621r serial #: (b)(6).Device manufacturer data: 04/23/2015 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? h4 device manufacturer date h6 event problem and evaluation codes h11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse station (cns, sn: (b)(6) was not alarming audibly when the gz transmitter (sn: (b)(6) had a low battery.Not in patient use.

• Brand Name: GZ-120P
• Common Device Name: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 23051588
• Report Number: 8030229-2025-05480
• Device Sequence Number: 10038589
• Product Code: MHX
• UDI-Device Identifier: 04931921117392
• UDI-Public: (01)04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GZ-120P
• Device Catalogue Number: GZ-120P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS.; CNS.
• Patient Sex: Unknown