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

Model Number	ZM-530PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the zm transmitter was giving intermittent spo2 readings.They were dropping from the central nurse's station (cns).It was confirmed that there were no error messages given when the readings dropped.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the zm transmitter was giving intermittent spo2 readings.They were dropping from the central nurse's station (cns).It was confirmed that there were no error messages given when the readings dropped.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: 10/03/2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, but was only able to provide the model information of the display that was connected to the associated cns.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns display: model #: rap2423amii serial #: (b)(6).Device manufacturer data:.Unique identifier (udi) #:.Returned to nihon kohden:.
Event or Problem Description
The customer reported that the zm transmitter gave intermittent spo2 readings.They were dropping from the central nurse's station (cns).It was confirmed there were no error messages given when the readings dropped.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the zm transmitter gave intermittent spo2 readings.They were dropping from the central nurse's station (cns).It was confirmed there were no error messages given when the readings dropped.No patient harm was reported.Investigation summary: multiple attempts were made to collect additional information regarding the complaint and to have the device brought in for evaluation.However, there has been no response from the customer.As such, there is not enough information to perform an investigation.Nihon kohden will continue to trend and monitor.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/03/2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, but was only able to provide the model information of the display that was connected to the associated cns.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns display: model #: rap2423amii.Serial #: (b)(6).Device manufacturer data: na.Unique identifier (udi) #: na.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.

• 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: 23381124
• Report Number: 8030229-2025-05705
• Device Sequence Number: 21012042
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2017
• 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: CNS (DISPLAY); CNS (DISPLAY)
• Patient Sex: Unknown