MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-140PA; TRANSMITTER

Model Number	GZ-140PA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm reported.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: concomitant medical device: the following devices were being used in conjunction with the gz-140pa telemetry transmitter.Central nurse's station: model: cns-6201a, sn: (b)(4).
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm reported.
Event or Problem Description
The biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer reported that the telemetry transmitter was not displaying waveforms and only displaying numerics.No patient harm was reported.Investigation summary: nihon kohden technical support (nk ts) reached out to clinical information technical support (cits) who was in the process of rebooting the universal gateway (ug) to troubleshoot another complaint.The ug reboot resolved the issue and the gz transmitter began to show waveforms again.The root cause is determined to be the facility's network environment.

• Brand Name: GZ-140PA
• Common Device Name: 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10360506
• Report Number: 8030229-2020-00419
• Device Sequence Number: 6962633
• Product Code: DRT
• UDI-Device Identifier: 04931921128244
• UDI-Public: 04931921128244
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/01/2023
• Report Date (Section F): 08/03/2020

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-140PA
• Device Catalogue Number: GZ-140PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2020
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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-6201A SN (B)(6); CNS-6201A SN (B)(6); CNS-6201A SN (B)(4).
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/03/2020