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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org is dropping its signal on transmitters that are attached to it.No consequence or impact to the patients were reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the org is dropping its signal on transmitters that are attached to it.No consequence or impact to the patient.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019 customer reported several orgs were in communication loss, spread throughout the hospital on different cns devices.Devices show up on the host table but displayed communication loss.Some of these orgs were in a separate building across the hospital.Nk ts identified the network switches, including the one across the hospital, ran back to a data center with fiber connections.The following cns were involved: 10.13.97.29, 10.13.97.25, 10.13.97.22, and 10.13.97.11.The following orgs were reported to have communication loss: 10.13.97.70, 10.13.97.71, 10.13.97.72, 10.13.97.73, 10.13.97.63, 10.13.97.65, 10.13.97.75, and 10.13.97.77.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: nk support engineer noted the issue was not with nk connection since devices can be seen in the host table and were picking up on packet captures.It was noted that the host1000 server host table entries were "out of balance." nk support engineer fixed the host tables so that they were no longer giving out errors.This did not alleviate the communication loss issue.The following questions were asked by the nk support engineer in aiding the troubleshooting effort: -could the hospital's infrastructure have an issue? -was there some sort of traffic that truly was not making it over to the data center? nk network engineer examined the issue and did not find any problem with the uplink between all the access closets back to the data center.It was noticed that ports for org's were flickering between up and down every once in a while, on the log screen between 03:52 and 04:42 (b)(6) 2019.Orgs were pinged successfully from the core switch and the servers.Wireshark on.97 host server shows proper broadcast packets every 16sec for the org's.On the same day, (b)(6) 2019, customer melissa responded that the issue was resolved by re-setting the orgs that corresponded to the communication loss sectors.Everything was working again.Customer stated that when the orgs were reset before, the waves did not come back.The switches were still flashing orange and green.Information regarding movement or maintenance of host table is not provided.Although the root cause could not be determined due the lack of information, the issue was resolved after having the orgs rebooted the second time, after host-table balancing.Was affecting the entire network.Investigation is in progress.Further investigation results will be documented on ticket 72625.Current information does not indicate a trend of network-wide communication loss at this facility.Service history for this user facility shows other communication loss issues that were isolated to individual devices.One incident reported under ticket (b)(4)on (b)(6) 2019 reported intermittent communication loss on the network.It is unknown if the issue was affecting the entire network.Investigation is in progress.Further investigation results will be documented on ticket (b)(4).Current information does not indicate a trend of network-wide communication loss at this facility.Investigation conclusion: information regarding movement or maintenance of host table is not provided.Although the root cause could not be determined due the lack of information, the issue was resolved after having the orgs rebooted the second time, after host-table balancing.Host table contains ip addresses of cns, rns devices, and servers which enable cross-segment communication.This host table is maintained by hospital personnel.Communication issues arise when the hospital moves, adds, or removes devices from the network without properly updating this host table.Corrected information: c11 & c2.Concomitant medical products: changed from not applicable to zm-521's and zm-541's.No serial numbers were provided.Changed from not applicable to cns devices.No models and serials numbers were provided.F9.Approximate age of device: changed from 52 months to 51 months.

Event Description

The customer reported that the org is dropping its signal on transmitters that are attached to it.No consequence or impact to the patient.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8557971
• MDR Text Key: 144409367
• Report Number: 8030229-2019-00117
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2020
• Distributor Facility Aware Date: 01/10/2020
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZM-521 DEVICESZM-541 DEVICESCNS DEVICES
• Patient Outcome(s): Required Intervention