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	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported that the spo2 connection continues to drop.He noted no errors or messages appeared when the connection would drop.He confirmed he swapped the cables with known working spo2 cables, and the issue persisted.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: pu-681ra sn: (b)(6).
Event or Problem Description
The biomedical engineer (bme) reported that the spo2 connection continues to drop.He noted no errors or messages appeared when the connection would drop.He confirmed he swapped the cables with known working spo2 cables, and the issue persisted.No patient harm was reported.
Additional Manufacturer Narrative
Reported that the spo2 connection continues to drop.He noted no errors or messages appeared when the connection would drop.He confirmed he swapped the cables with known working spo2 cables, and the issue persisted.Investigation conclusion: the returned device was cleaned, decontaminated, and inspected.Evidence of prior fluid exposure was observed, including residue in connectors and corrosion on battery contacts, along with cosmetic wear.The reported spo2 connection dropout could not be reproduced during extended functional testing with a simulator and continuous transmission to the receiver and cns over approximately 48 hours.As a precaution, internal components, including the spo2 board, were replaced, and post-repair testing confirmed the device operated within manufacturer specifications.The root cause could not be determined.Additional device information: d10: concomitant medical device: central nurse's station.Model: pu-681ra.Sn: (b)(6).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 spo2 connection continues to drop.He noted no errors or messages appeared when the connection would drop.He confirmed he swapped the cables with known working spo2 cables, and the issue persisted.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: 23302478
• Report Number: 8030229-2025-05647
• Device Sequence Number: 15934296
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/15/2026

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: 10/07/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2017
• 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: PU-681RA SN (B)(6). ; PU-681RA SN (B)(6).
• Patient Sex: Unknown