MAUDE Adverse Event Report: Nihon Kohden Corporation ZM-531PA; Telemetry Transmitter

Model Number	ZM-531PA
Medical Device Problem Codes	Unable to Obtain Readings (1516); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The biomedical engineer (biomed) reported that on (b)(6) 2026, during a patient transport, the zm transmitter went into signal loss, and the biomed believes (but cannot 100% confirm) there was a break in data at the central nurse's station (cns) during the period of signal loss.The signal loss failed to alert staff of the patient's condition which ultimately led to the patient experiencing a seizure.
Additional Manufacturer Narrative
The biomedical engineer (biomed) reported that on (b)(6) 2026, during a patient transport, the zm transmitter went into signal loss, and the biomed believes (but cannot 100% confirm) there was a break in data at the central nurse's station (cns) during the period of signal loss.The signal loss failed to alert staff of the patient's condition which ultimately led to the patient experiencing a seizure.He adds that the report does not mention that the patient coded, and believes this incident only revolves around patient harm.It was also mentioned that prior to this incident, the facility had been experiencing intermittent signal loss with their telemetry units in the icu, er, and pcu departments.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: a2-a6; b6; b7.Attempt # 1: (b)(6) 2026 emailed the customer via microsoft outlook for the information in the ni list above: hospital superiors declined to fill out and send in the adverse event form due to hipaa violation concerns.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: cns-2101, serial #: (b)(6), device manufacturer data: 03/08/2024, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.

• 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: 50614853
• Report Number: 8030229-2026-07104
• Device Sequence Number: 10711538
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: (01)04931921115107
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 09/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2017
• 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: Central Nurse's Station (CNS-2101).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown