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

Model Number	ORG-9100A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the ecg readings were fluctuating at the central nurse station (cns) (pu-681ra sn: (b)(6) when testing a zm transmitter, tele 8, (model & sn unknown) on a simulator with the multiple patient receiver (org-9100a, sn: (b)(6).No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the ecg readings were fluctuating at the central nurse station (cns) (pu-681ra sn: (b)(6) when testing a zm transmitter, tele 8, (model & sn unknown) on a simulator with the multiple patient receiver (org-9100a, sn: (b)(6).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.The following field contain no information (ni), as attempts to obtain the information were made, but not provided: d10 04/28/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 05/12/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 05/16/2025 emailed the bme for all information in the ni list above: the bme replied with the cns information but did not have the transmitters' information.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: cns: model #:pu-681ra serial #: (b)(6) device manufacturer data: 02/15/2021 (feb.15, 2021) unique identifier (udi) #: (b)(4).Zm transmitters: model #:ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the ecg readings were fluctuating at the central nurse station (cns) (pu-681ra sn: (b)(6)) when testing a zm transmitter, tele 8, (model & sn unknown) on a simulator with the multiple patient receiver (org-9100a, sn: (b)(6)).No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the ecg readings were fluctuating at the central nurse station (cns) (pu-681ra sn: (b)(6)) when testing a zm transmitter, tele 8, (model & sn unknown) on a simulator with the multiple patient receiver (org-9100a, sn: (b)(6)).No patient harm was reported.Investigation summary: sporadic ecg readings (fluctuating between 90-120 bpm) on tele 8, despite stable readings on the simulator.Nk tech support advised testing a different telemetry unit with the same receiver, which confirmed the issue was with the receiver.The biomed replaced the receiver card in the org, resolving the problem.The cns involved was a pu-681ra (sn: (b)(6)).The issue resolved when the customer replaced the receiver cards in the org.Root cause determined to be component failure of the org receiver card due to aging.The device was installed on (b)(6) 2008.The root cause is likely related to device aging.The following field contain no information (ni), as attempts to obtain the information were made, but not provided: d10 04/28/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 05/12/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 05/16/2025 emailed the bme for all information in the ni list above: the bme replied with the cns information but did not have the transmitters' information.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org:.Cns:.Model #:pu-681ra.Serial #: (b)(6).Device manufacturer data: 02/15/2021 (feb.15, 2021).Unique identifier (udi) #: (b)(4).Zm transmitters: model #:ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.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-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: 22075556
• Report Number: 8030229-2025-04938
• Device Sequence Number: 15631051
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/18/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2008
• 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: CNS; CNS; ZM TRANSMITTERS; ZM TRANSMITTERS
• Patient Sex: Unknown