MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TELEMETRY TRANSMITTER

Model Number	ZM-531PA
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the zm transmitter was experiencing intermittent dropouts during patient use.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the zm transmitter was experiencing intermittent dropouts during patient use.The patient was moved to a hardwire bed to continue monitoring.The bme was able to duplicate the issue when they tested the zm unit in their shop.No reports of patient harm.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided.
Event or Problem Description
The biomedical engineer (bme) reported that the zm transmitter was experiencing intermittent dropouts during patient use.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the zm transmitter was experiencing intermittent dropouts during patient use.The patient was moved to a hardwire bed to continue monitoring.The bme was able to duplicate the issue when they tested the zm unit in their shop.No reports of patient harm.Investigation summary: the complaint device was returned to nihon kohden for evaluation.The evaluation remarked on evidence of previous fluid exposure, but the reported issue could not be duplicated.Without replicating the issue, a definitive root cause cannot be established.At the time of complaint reporting, the presence of fluids may have caused or contributed to the observed issue, but the device had sufficiently dried by the time of evaluation at nihon kohden.Alternatively, the issue may have been caused by an environmental factor at the customer facility.A review of the device's complaint history by serial number reveals no similar issues.Nihon kohden will continue to trend and monitor.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 01/19/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 01/26/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 3: 02/02/2026 emailed the bme for the information in the ni list above: no reply was received.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.

• Brand Name: ZM-531PA
• 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: 24309980
• Report Number: 8030229-2026-06148
• Device Sequence Number: 5142442
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: (01)04931921115107
• 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): 05/06/2026

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-531PA
• Device Catalogue Number: ZM-531PA
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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
• Patient Sex: Unknown