MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-540PA; TELEMETRY TRANSMITTER

Model Number	ZM-540PA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that they could only see one lead under the 12-lead data page on the central nurse station (cns) for this zm transmitter.They transferred the patient from a zm-530 unit to this one, using the same ecg cable, but they were previously able to see eight leads.The same issue was present on all their zm-540 models only.Technical support informed them to check that the parameter setup on the device itself was set to 6-lead instead of auto.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: the following device was used in conjunction with the transmitter: cns: model #:ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.
Event or Problem Description
The nurse reported that they could only see one lead under the 12-lead data page on the central nurse station (cns) for this zm transmitter.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that they could only see one lead under the 12-lead data page on the central nurse station (cns) for this zm transmitter.They transferred the patient from a zm-530 unit to this one, using the same ecg cable, but they were previously able to see eight leads.The same issue was present on all their zm-540 models only.Technical support informed them to check that the parameter setup on the device itself was set to 6-lead instead of auto.No patient harm was reported.Investigation summary: insufficient information / no product returned multiple attempts were made to collect additional information regarding the complaint.However, the customer replied that they did not have this information available.There is not enough information to perform an investigation.The complaint could not be confirmed.Root cause could not be determined.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model#: ni, serial#: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: na.Additional information: b4: date of this report, g3: date received by manufacturer, g6: type of report, h2: if follow-up, what type? h6: event problem and evaluation codes, h11: additional manufacturer narrative.
Event or Problem Description
The nurse reported that they could only see one lead under the 12-lead data page on the central nurse station (cns) for this zm transmitter.No patient harm was reported.

• Brand Name: ZM-540PA
• 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: 23133264
• Report Number: 8030229-2025-05544
• Device Sequence Number: 15774288
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: (01)04931921106600
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2010
• 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.; CNS.
• Patient Sex: Unknown