MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number	ORG-9100A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported experiencing communication loss errors involving four zm transmitters monitored at the central nurse station (cns-2101a, (b)(6) using the multiple patient receiver (org).All three indicator lights on the org were illuminated.The nurse rebooted the cns, but the issue persisted.Technical support (ts) instructed them to power cycle the org for two minutes and replace the network cable; however, the problem 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.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: cns, model #: cns-2101, serial #:(b)(6), unique identifier (udi) #: (b)(4), returned to nihon kohden: na.Zm transmitters: model #: zm-530pa, serial #: (b)(6), device manufacturer data: 08/12/2020, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.Zm transmitter: model #: zm-530pa, serial #: (b)(6), device manufacturer data: 08/20/2020, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Event or Problem Description
The nurse reported experiencing communication loss errors involving four zm transmitters monitored at the central nurse station (cns) using the multiple patient receiver (org).No patient harm was reported.
Event or Problem Description
The nurse reported experiencing communication loss errors involving four zm transmitters monitored at the central nurse station (cns) using the multiple patient receiver (org).No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the nurse reported experiencing communication loss errors involving four zm transmitters monitored at the central nurse station (cns-2101a, (b)(6)) using the multiple patient receiver (org).All three indicator lights on the org were illuminated.The nurse rebooted the cns, but the issue persisted.Technical support (ts) instructed them to power cycle the org for two minutes and replace the network cable; however, the problem persisted.No patient harm was reported.Investigation summary: the reported issue was duplicated, and the device had an error light that would result in communication loss.Multiple attempts at initialization did not resolve the error light, and the cause was determined to be fault in the ur-3981 cpu board.A review of the device's complaint history reveals two previous tickets, tickets (b)(4), relating to communication loss.The former was addressed with replacement of the ur-39801 zr mother board and receiver cards, while the latter could not be duplicated.Nihon kohden will continue to trend and monitor.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: cns.Model #: cns-2101, serial #: (b)(6), unique identifier (udi) #: (b)(4), returned to nihon kohden: na.Zm transmitters: model #: zm-530pa, serial #: (b)(6), device manufacturer data: 08/12/2020, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.Zm transmitter: model #: zm-530pa, serial #: (b)(6), device manufacturer data: 08/20/2020, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.Additional information: b4.Date of this report, d9.Device available for evaluation, g3.Date received by manufacturer, g6.Type of report, h2.If follow-up, what type? h3.Device evaluated by manufacturer, h6.Event problem and evaluation codes, h11.Additional manufacturer narrative.

• Brand Name: ORG-9100A
• 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: 23652526
• Report Number: 8030229-2025-05778
• Device Sequence Number: 11967873
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2013
• 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.; ZM TRANSMITTERS.; ZM TRANSMITTERS.
• Patient Sex: Unknown