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

Model Number	ZM-530PA
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this zm transmitter does not show the heart sign while spo2 connected.Technical support (ts) asked if they had the spo2 connected and no ecg cable.Ts informed the customer that if this was the case, the heart rate (hr) icon will not show unless the ecg measurement is turned off in the deep end settings on the transmitter.Ts went on to say that on the other hand if the ecg measurement setting is turned on in the deep settings and only the spo2 cable is connected then they would see a pr numerical along with the spo2 numerical.It is unknown if the unit was in patient use at the time.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: 01/09/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 01/12/2026 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 01/14/2026 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.The following fields are not available (n/a) to this report: h4 device manufacturer date.
Event or Problem Description
The customer reported that this zm transmitter does not show the heart sign while spo2 connected.It is unknown if the unit was in patient use at the time.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this zm transmitter does not show the heart sign while spo2 connected.Technical support (ts) asked if they had the spo2 connected and no ecg cable.Ts informed the customer that if this was the case, the heart rate (hr) icon will not show unless the ecg measurement is turned off in the deep end settings on the transmitter.Ts went on to say that on the other hand if the ecg measurement setting is turned on in the deep settings and only the spo2 cable is connected then they would see a pr numerical along with the spo2 numerical.It is unknown if the unit was in patient use at the time.Investitation summary: the device was not returned for evaluation; however, the customer later reported that the issue had been resolved, but did not provide details of how the issue was resolved.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h4 device manufacturer date h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this zm transmitter does not show the heart sign while spo2 connected.It is unknown if the unit was in patient use at the time.

• 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: 24073710
• Report Number: 8030229-2026-06050
• Device Sequence Number: 16009077
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/25/2026

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: 12/18/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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