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

Model Number ORG-9110A

Device Problems No Display/Image (1183); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) is not showing the heart rate (hr) numeric value on the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) is not showing the heart rate (hr) numeric value on the central nurse's station (cns).Nihon kohden technical support account manager (tsam) was on-site and found that changing the lead settings on the cns resolved it this time, they moved the analysis leads to v1 and v3.For some reason, it was monitoring lead 1 for both traces.When it was changed to v1/v3, the other leads greyed out and could no longer be selected.Customer is using disposable leads, nk tsam tried nk leads with the same issue.Customer is returning the org-9110a device to nk.There was no patient injury reported.Service performed: nihon kohden repair center (nkrc) received the customer's device.Nkrc tested the org and found they could not duplicate the heart rate (hr) not showing on the device.Evaluation found the unit had error messages after the 24 hour testing and nkrc reinstalled software ver 05-01 and initialized the unit to resolve the error message issues and unit passes all testing and was returned to the customer.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(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6)2025 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6)2025 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6)2025 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6)2025 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) is not showing the heart rate (hr) numeric value on the central nurse's station (cns).Nihon kohden technical support account manager (tsam) was on-site and found that changing the lead settings on the cns resolved it this time, they moved the analysis leads to v1 and v3.For some reason, it was monitoring lead 1 for both traces.When it was changed to v1/v3, the other leads greyed out and could no longer be selected.Customer is using disposable leads, nk tsam tried nk leads with the same issue.Customer is returning the org-9110a device to nk.There was no patient injury reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) is not showing the heart rate (hr) numeric value on the central nurse's station (cns).Nihon kohden technical support account manager (tsam) was on-site and found that changing the lead settings on the cns resolved it this time, they moved the analysis leads to v1 and v3.For some reason, it was monitoring lead 1 for both traces.When it was changed to v1/v3, the other leads greyed out and could no longer be selected.Customer is using disposable leads, nk tsam tried nk leads with the same issue.Customer is returning the org-9110a device to nk.There was no patient injury reported.Service performed: nihon kohden repair center (nkrc) received the customer's device.Nkrc tested the org and found they could not duplicate the heart rate (hr) not showing on the device.Evaluation found the unit had error messages after the 24 hour testing and nkrc reinstalled software ver 05-01 and initialized the unit to resolve the error message issues and unit passes all testing and was returned to the customer.Investigation: nihon kohden has identified some org issues, which are not limited to, user related error, incorrect settings, installation issues, file or software corruption, (due to a user relate error, such as an ungraceful exit or shutdown, which can cause corruption and setting related issues), battery issues, hardware/component failure issues, customer facility it (information technology) issues or network environmental issues (including power supply or power plug in outlet issues).Issues with org devices can be mitigated by our nk ts team working with the customer, or the customer working with their it department to resolve such issue.If the issue is determined to be related to damage, the damaged device, component and or accessories/cable or hardware used with the device, can be either repaired or replaced to resolve any damage issues.A review of historical data, for device, (org-9110a, serial number 2889), did not reveal any trends that would contribute to component failure that is related to the design or manufacturing of the device.Moreover, this was found to be the only issue at the facility in the past 3 (three) years for this device and issue.As such, this is an isolated issue, and a significant trend that would warrant any further corrective action has not been observed.

• Brand Name: ORG-9110A
• Type of Device: 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: 16828331
• MDR Text Key: 314533112
• Report Number: 8030229-2023-03474
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS; ZM TRANSMITTERS; ZM TRANSMITTERS