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	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this org displays a communication loss (comm loss) intermittently on the only 2 patients that were admitted.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this org displays a communication loss (comm loss) intermittently on the only 2 patients that were admitted.There was no patient injury 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 Manufacturer Narrative
Details of complaint: the customer reported that this org displays a communication loss (comm loss) intermittently on the only 2 patients that were admitted.There was no patient injury reported.Investigation summary: the returned device was evaluated and the reported issue could not be duplicated.No device malfunction was identified.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 09/04/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 09/07/2025 i called roger to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for roger to call me back with this information.Attempt # 3: 09/09/2025 i called roger to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for roger to call me back with this information.Additional information: b4 date of this report d9 is this device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this org displays a communication loss (comm loss) intermittently on the only 2 patients that were admitted.There was no patient injury 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: 23006614
• Report Number: 8030229-2025-05385
• Device Sequence Number: 10484774
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/03/2025

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: 08/12/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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