MAUDE Adverse Event Report: Nihon Kohden Corporation ZM-540PA; Telemetry Transmitter

Model Number	ZM-540PA
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that this transmitter failed the air leak test and shuts down.Discovered during testing and not in patient use.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 transmitter failed the air leak test and shuts down.Discovered during testing and not in patient use.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that this transmitter failed the air leak test and shuts down.Discovered during testing and not in patient use.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that this transmitter failed the air leak test and shuts down.Discovered during testing and not in patient use.No patient harm was reported.Investigation summary: physical inspection confirmed the model and serial number, and no physical damage was observed; however, signs of liquid exposure were noted.Functional testing was performed connecting the unit to an ax-400g simulator and monitoring through a cns-2101a system with an org-9100a, testing all ecg leads and spo2 functionality, with nibp function also tested using an sc-3 pronk simulator.The reported issue could not be duplicated, and the unit was continuously tested for over 48 hours with no air leak, shutdowns, or other abnormalities observed.The unit passed all functional tests successfully.Possible root cause: air leak from damaged nibp cuff no further investigation is required.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 h6 event problem and evaluation codes.H11 additional manufacturer narrative.

• 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: 25505346
• Report Number: 8030229-2026-06738
• Device Sequence Number: 13388517
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: (01)04931921106600
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/27/2026

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-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2010
• 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: NA.
• Patient Sex: Unknown