MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TELEMETRY TRANSMITTER

Model Number	ZM-530PA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that they have artifact in the waveforms.New lead sets tried, but the issue persists.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they have artifact in the waveforms.New lead sets tried, but the issue persists.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: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1 11/03/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/10/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 11/12/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station model: ni sn: ni.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they have artifact in the waveforms.New lead sets tried, but the issue persists.No patient harm was reported.Investigation conclusion: the customer reported that the transmitter (zm-530pa, sn: (b)(6)) had artifacts in the waveforms.An exchange unit was sent to the customer, and the complaint device was returned for evaluation.The evaluation noted signs of previous moisture exposure, but the reported issue could not be replicated.As such, a definitive root cause cannot be established.It's possible that the presence of fluid resulted in reduced device performance at the time of complaint reporting, but the device had sufficiently dried by the time of evaluation.The device's center case, which contains the ecg socket, was replaced as a preventative measure, and the device continued to perform to manufacturer's specifications.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device attempt #1 11/03/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/10/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 11/12/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station.Model: ni.Sn: ni.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 they have artifact in the waveforms.New lead sets tried, but the issue persists.No patient harm was reported.

• Brand Name: ZM-530PA
• 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: 23550218
• Report Number: 8030229-2025-05809
• Device Sequence Number: 18571664
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/10/2026

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: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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; CENTRAL NURSE'S STATION
• Patient Sex: Unknown