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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (biomed) reported that the multiple patient receiver (org) was showing comm loss for all 8 receiver cards.Each receiver card successively going into comm loss throughout the day until they were all in comm loss.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (biomed) reported that the multiple patient receiver (org) was showing comm loss for all 8 receiver cards.Each receiver card successively going into comm loss throughout the day until they were all in comm loss.This device was a loner, and they had received the original device back but had not yet swapped it back in.Technical support (ts) recommended that he reboot the org, replace the ethernet cable, and move the device to a different network port.He later confirmed that making these changes did not resolve the issue.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 (biomed) reported that the multiple patient receiver (org) was showing comm loss for all 8 receiver cards.Each receiver card successively going into comm loss throughout the day until they were all in comm loss.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (biomed) reported that the multiple patient receiver (org) was showing comm loss for all 8 receiver cards.Each receiver card successively going into comm loss throughout the day until they were all in comm loss.This device was a loner, and they had received the original device back but had not yet swapped it back in.Technical support (ts) recommended that he reboot the org, replace the ethernet cable, and move the device to a different network port.He later confirmed that making these changes did not resolve the issue.No patient harm was reported.Investigation summary: multiple attempts have been made to request additional information.However, there was no response received.As such, this complaint could not be confirmed, and the root cause of the reported issue could not be determined.No further investigation will be performed.Nk will continue to monitor and trend.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? 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: 50131457
• Report Number: 8030229-2026-06950
• Device Sequence Number: 13393771
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: (01)04931921103906
• 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
• Report Date (Section B): 08/04/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2018
• 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