MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number	ORG-9110A
Medical Device Problem Codes	Unable to Obtain Readings (1516); Communication or Transmission Problem (2896); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) was in communication loss, and the error light was lit.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was in communication loss, and the error light was lit.Rebooting the org did not resolve the issue.No patient harm was reported.Investigation summary: the device was returned to nihon kohden for evaluation and repair.During evaluation, the reported issue was successfully duplicated, and the cpu pcb board was identified as the failed component.In this case, the device was initially installed at the facility on (b)(6)2012, indicating the device and its components have aged approximately 14 years.Aging devices and their components are susceptible to wear and tear damage and may need replacement over time from aging and degradation.After replacing the malfunctioning cpu pcb component, it passed all post-repair testing and inspection, meeting the manufacturer specifications in all areas.Nihon kohden will continue to trend and monitor.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.

• 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: 25857604
• Report Number: 8030229-2026-06857
• Device Sequence Number: 20150266
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: (01)04931921103906
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 07/17/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2011
• 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