MAUDE Adverse Event Report: Nihon Kohden Corporation ORG-9110A; Multiple Patient Receiver

Model Number	ORG-9110A
Medical Device Problem Codes	Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that a zm transmitter was intermittently experiencing signal loss and, when connected, was displaying artifacts and sporadic respiration rate (rr) waveforms.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that a zm transmitter was intermittently experiencing signal loss and, when connected, was displaying artifacts and sporadic respiration rate (rr) waveforms.A duplicate transmitter exhibited the same behavior on the same channel.Technical support (ts) instructed the bme to reassign the channel to a different bed and move it to a different receiver card on the multiple patient receiver (org).Normal operation was restored, indicating the issue was likely related to the org or one of its receiver cards.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.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: cns model #: cns-2101.Serial #: (b)(6).Device manufacturer data: (b)(6) 2024 ((b)(6)).Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitter: model #: zm-531pa.Serial #: (b)(6).Device manufacturer data: (b)(6) 2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

• Brand Name: ORG-9110A
• Common Device Name: Multiple Patient Receiver
• 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: 25201795
• Report Number: 8030229-2026-06588
• Device Sequence Number: 18383397
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: (01)04931921103906
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K071058
• 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): 08/12/2026

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: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2014
• 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.; ZM TRANSMITTER.
• Patient Sex: Unknown