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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the zm-530pa telemetry transmitter is showing excessive noise on the central nurse's station (cns).They stated that swapping the telemetry with a spare unit resolved the issue.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.Central nurse's station: model: cns-2101, sn: (b)(6).
Event or Problem Description
The biomedical engineer (bme) reported that the zm-530pa telemetry transmitter is showing excessive noise on the central nurse's station (cns).They stated that swapping the telemetry with a spare unit resolved the issue.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the zm-530pa telemetry transmitter is showing excessive noise on the central nurse's station (cns).They stated that swapping the telemetry with a spare unit resolved the issue.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the zm-530pa telemetry transmitter is showing excessive noise on the central nurse's station (cns).They stated that swapping the telemetry with a spare unit resolved the issue.No patient harm was reported.Investigation conclusion: the unit was returned to nihon kohden for evaluation and repair.The reported issue could not be duplicated, and a root cause cannot be definitively established.The device showed signs of previous moisture exposure, and there was residue in the center case assembly.It's possible that the presence of moisture impacted device performance at the time of complaint reporting.The device's center case was replaced as a preventative measure.Additional device information: d10 concomitant medical device.Central nurse's station: model: cns-2101.Sn: (b)(6).

• 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: 23834860
• Report Number: 8030229-2025-05919
• Device Sequence Number: 18458557
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/16/2026

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
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: CNS-2101, SN (B)(6).; CNS-2101, SN (B)(6).
• Patient Sex: Unknown