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	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multiple patient receiver (org) has an error light.The unit does not seem to be connected to the network and cannot be viewed on the host table.Beds 202-211 show comm-loss.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 telemetry transmitter model: zm-530pa sn: (b)(6).Telemetry transmitter model: zm-530pa sn: (b)(6).Telemetry transmitter model: zm-530pa sn: (b)(6).Telemetry transmitter model: zm-530pa sn: (b)(6).Telemetry transmitter model: zm-530pa sn: (b)(6).
Event or Problem Description
The customer reported that the multiple patient receiver (org) has an error light.The unit does not seem to be connected to the network and cannot be viewed on the host table.Beds 202-211 show comm-loss.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the multiple patient receiver (org) has an error light.The unit does not seem to be connected to the network and cannot be viewed on the host table.Beds 202-211 show comm-loss.No patient harm was reported.Investigation conclusion: the evaluation identified damage to the chassis shield plate, and the reported error light issue was replicated.The cause of the complaint was determined to be malfunction of the ur-3981 cpu board.The device performed to manufacturer's specifications after component replacement.The device had been installed at the customer facility since (b)(6) 2015, and the hardware failure is presumed to be related to wear and tear.A review of the device's complaint history by serial number reveals one similar issue in ticket (b)(4).For which, the communication issue was resolved at the customer facility, and the root cause was related to third-party product and network environment.Additional device information: d10.Concomitant medical device.Telemetry transmitter: model: zm-530pa, sn: (b)(6).Telemetry transmitter: model: zm-530pa, sn: (b)(6).Telemetry transmitter: model: zm-530pa, sn: (b)(6).Telemetry transmitter: model: zm-530pa, sn: (b)(6).Telemetry transmitter: model: zm-530pa.Sn: (b)(6).Additional information: b4.Date of this report.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.
Event or Problem Description
The customer reported that the multiple patient receiver (org) has an error light.The unit does not seem to be connected to the network and cannot be viewed on the host table.Beds 202-211 show comm-loss.No patient harm was reported.

• 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: 24126652
• Report Number: 8030229-2026-06035
• Device Sequence Number: 18475360
• 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: Biomedical Engineer
• 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
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2014
• 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: ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).; ZM-530PA SN (B)(6).
• Patient Sex: Unknown