MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TELEMETRY TRANSMITTER

Model Number	ZM-520PA
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the telemetry transmitter will no longer read the va lead.No patient harm was 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: d10 concomitant medical device.Multiple patient receiver.Model: org-9700a.Sn: (b)(6).Central nurse's station.Model: ni.Sn: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry transmitter will no longer read the va lead.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the telemetry transmitter will no longer read the va lead.No patient harm was reported.Investigation conclusion: the customer reported that a zm-520pa transmitter would no longer read the va lead.The customer attempted swapping to a validated known-good lead set with no change.Nk tech support informed the customer that the zm-520pa is end-of-service (eos) and that units outside the warranty period cannot be repaired or exchanged.An eos letter was provided to the customer, and the ticket was resolved.Troubleshooting confirmed the va lead remained nonfunctional even with known-good lead sets.The device could not be evaluated further due to eos status, and the root cause could not be determined.Additional device information: d10 concomitant medical device.Multiple patient receiver.Model: org-9700a.Sn: (b)(6).Central nurse's station.Model: ni.Sn: ni.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 telemetry transmitter will no longer read the va lead.No patient harm was reported.

• Brand Name: ZM-520PA
• Common Device Name: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• 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: 23069132
• Report Number: 8030229-2025-05504
• Device Sequence Number: 10044952
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: (01)04931921115077
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• 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): 12/07/2025

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: ZM-520PA
• Device Catalogue Number: ZM-520PA
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2018
• 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 MODEL NI; CNS MODEL NI; ORG-9700A 00096; ORG-9700A 00096
• Patient Sex: Unknown