MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TELEMETRY TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that this zm transmitter was experiencing intermittent signal loss.This was the only unit behaving this way.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.
Event or Problem Description
The biomedical engineer (bme) reported that this zm transmitter was experiencing intermittent signal loss.This was the only unit behaving this way.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that this zm transmitter was experiencing intermittent signal loss.This was the only unit behaving this way.No patient harm was reported.Investigation summary: the reported issue was confirmed, and the root cause of the reported issue is due to mechanical failure within the top case assembly.All affected components have been replaced with new ones.The unit was tested following the operator's manual.After an extensive testing period of 24 hours, the unit was found to be operating within the manufacturer's specifications.No further investigation will be performed.There was no patient involvement, no injury, no harm, nor any adverse event, due to the reported issue.Trending will continue to be monitored for this device, incidents, issues, and causes.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 01/29/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 02/12/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 3: 02/16/2026 emailed the bme for the information in the ni list above: no reply was received.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.H3 device evaluated by manufacturer.H4 device manufacture date.H6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that this zm transmitter was experiencing intermittent signal loss.This was the only unit behaving this way.No patient harm was reported.

• Brand Name: ZM-541PA
• 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: 24414568
• Report Number: 8030229-2026-06186
• Device Sequence Number: 5939675
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: (01)04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/19/2026

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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