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

Model Number	GZ-130P
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint:\ the biomedical engineer (bme) reported that the gz transmitter's screen goes dark while being used, then was unresponsive despite pressing any of the buttons.No patient harm was reported.\ \ investigation summary:\ the device was returned to nihon kohden for evaluation.The evaluation remarked on signs of previous fluid exposure.The reported issue was replicated, and the cause of the issue was determined to be a hardware failure relating to the display switch.\ a review of the device's complaint history by serial number reveals no similar issues.Nihon kohden will continue to trend and monitor.\ \ 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.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter's screen goes dark while being used, then was unresponsive despite pressing any of the buttons.No patient harm was reported.

• 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: 50068736
• Report Number: 8030229-2026-06852
• Device Sequence Number: 15982861
• 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
• Report Date (Section B): 07/29/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sex: Unknown