MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TELEMETRY TRANSMITTER

Model Number	ZM-530PA
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the zm transmitter was not displaying vitals at the central nurse station (cns).After being admitted, the options were greyed out.The bme tested the zm on a simulator and confirmed the vitals were displaying on the unit itself, but not on the cns.Technical support (ts) had them stop/restart monitoring the zm, but the issue persisted.Ts advised they try rebooting the multiple patient receiver (org), but the issue persisted.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 01/08/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 01/14/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 3: 01/20/2026 emailed the bme for the information in the ni list above: the bme replied, stating that the requested information will not be provided.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 11/09/2018 (nov.) unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Org: model #: org-9100a.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the zm transmitter was not displaying vitals at the central nurse station (cns).No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the zm transmitter was not displaying vitals at the central nurse station (cns).After being admitted, the options were greyed out.The bme tested the zm on a simulator and confirmed the vitals were displaying on the unit itself, but not on the cns.Technical support (ts) had them stop/restart monitoring the zm, but the issue persisted.Ts advised they try rebooting the multiple patient receiver (org), but the issue persisted.No patient harm was reported.Investigation summary: a reboot of the org was recommended as the next step but was not completed.The customer confirmed the issue was isolated to the transmitter and elected to repair the unit in-house rather than send it in for service.Root cause: could not be determined.No further investigation is required.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 01/08/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 01/14/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 3: 01/20/2026 emailed the bme for the information in the ni list above: the bme replied, stating that the requested information will not be provided.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: pu-681ra serial #: 00801 device manufacturer data: 11/09/2018 (nov.) unique identifier (udi) #: 04931921131640 returned to nihon kohden: na org: model #: org-9100a serial #: ni device manufacturer data: ni unique identifier (udi) #: 04931921103883 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 biomedical engineer (bme) reported that the zm transmitter was not displaying vitals at the central nurse station (cns).No patient harm was reported.

• Brand Name: ZM-530PA
• Common Device Name: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 24184943
• Report Number: 8030229-2026-06089
• Device Sequence Number: 21336356
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/01/2026

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-530PA
• Device Catalogue Number: ZM-530PA
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2019
• 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; ORG; ORG
• Patient Sex: Unknown