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

Model Number	ORG-9100A
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	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the org was constantly in intermittent comm loss.They tried rebooting the org, swapping out the ethernet cable, and tried a different port on the switch, but the issue 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.
Event or Problem Description
The biomedical engineer (bme) reported that the org was constantly in intermittent comm loss.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the org was constantly in intermittent comm loss.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the org was constantly in intermittent comm loss.They tried rebooting the org, swapping out the ethernet cable, and tried a different port on the switch, but the issue persisted.No patient harm was reported.Investigation summary: it was later reported that the org was stuck in an error status in ticket (b)(4).The unit was returned for repair and evaluation on that ticket.During evaluation, the issue of an error light was confirmed and resolved through system initialization.The issue of communication loss preceding the error condition is presumed to have the same root cause of software corruption as in ticket (b)(4).The org performed to manufacturer's specifications after initialization.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/01/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 10/06/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 10/14/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.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?.H4 device manufacturer date.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: 23292990
• Report Number: 8030229-2025-05649
• Device Sequence Number: 4783409
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/09/2026

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: 09/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2014
• 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
• Patient Sex: Unknown