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

Model Number	GZ-120P
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the gz transmitter was experiencing intermittent signal loss and it would randomly turn off.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.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter was experiencing intermittent signal loss and it would randomly turn off.Not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the gz transmitter was experiencing intermittent signal loss and it would randomly turn off.Not in patient use.Investigation summary: insufficient information / no product returned multiple attempts were made to collect additional information regarding the complaint and facilitate device return.However, there has been no response from the customer.As such, there is insufficient information to establish a root cause or enough information to perform an investigation.The complaint device had been in use at the customer facility since (b)(6) 2020, and thus it had already exceeded its expected usage life at the time of complaint reporting.A review of the device's complaint history by serial number reveals no similar issues.Nihon kohden will continue to trend and monitor.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 08/15/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 08/29/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 09/05/2025 emailed the bme for all information in the ni list above: no reply was received.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.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter was experiencing intermittent signal loss and it would randomly turn off.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: 23025231
• Report Number: 8030229-2025-05461
• Device Sequence Number: 9216753
• 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): 12/02/2025

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: 08/13/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2019
• 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: NI.; NI.
• Patient Sex: Unknown