MAUDE Adverse Event Report: Nihon Kohden Corporation GZ-130P; Telemetry Transmitter

Model Number	GZ-130P
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the gz telemetry transmitter is constantly rebooting and not staying on.The bme swapped out the batteries with a new set and the issue still persists.Not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the gz telemetry transmitter is constantly rebooting and not staying on.The bme swapped out the batteries with a new set and the issue still persists.Not in patient use.Investigation conclusion: the device was returned to nihon kohden for evaluation.The evaluation remarked on signs of liquid exposure and poor overall condition.The reported issue was replicated, and the cause was attributed to circuit board failure.The device was deemed ineligible for repair and designated for scrapping.Additional information: b4 date of this report d9 device available for evaluation g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer h6 event problem and evaluation codes.H11 additional manufacturer narrative.

• Brand Name: GZ-130P
• 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: 50113076
• Report Number: 8030229-2026-06841
• Device Sequence Number: 10753410
• Product Code: MHX
• UDI-Device Identifier: 04931921117415
• UDI-Public: (01)04931921117415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/02/2026

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-130P
• Device Catalogue Number: GZ-130P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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: Central Nurse's Station.
• Patient Sex: Unknown