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

Model Number ORG-9110A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 08/15/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org's) keep losing connectivity and shows communication loss with connected device(s).No patient harm was reported.Nihon kohden's technician advised the bme to work with their it department due to having nihon kohden's equipment running off of their facilities network which means the switches being used for the org's are serviced by the facilities it department.

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org's) keep losing connectivity and shows communication loss with connected device(s).No patient harm was reported.Nihon kohden's technician advised the bme to work with their it department due to having nihon kohden's equipment running off of their facilities network which means the switches being used for the org's are serviced by the facilities it department.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.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receivers (orgs) kept losing connectivity and showed comm loss with the connected devices.Nihon kohden's technical support (nk ts) advised the bme to work with their local it department to troubleshoot the switches that were in use for the orgs, which were serviced by the facility's it department.No patient harm or injury was reported.Investigation summary: nk ts asked the customer to reboot the org and the issue appeared resolve.The customer called back on 08/16/2021 and stated the issue had returned.An nk ts review found a related ticket ((b)(4)), reported on 08/13/2021.Nk ts requested that the customer verify that no ip addresses were duplicated.The customer had been power cycling org when the comm loss occurred, which appeared to resolve the issue, then it would return later.Nk ts suggested power cycling the switch.The facility's it was contacted, and the switch was power cycled.The root cause is determined to be the facility's network environment.The network switch needed to be rebooted.Review of the serial number history shows no recurrence of reported issue.

Event Description

The biomedical engineer (bme) reported that the multiple patient receivers (orgs) kept losing connectivity and showed comm loss with the connected devices.Nihon kohden's technical support advised the bme to work with their local it department to troubleshoot the switches that were in use for the orgs, which were serviced by the facility's it department.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12456879
• MDR Text Key: 283501100
• Report Number: 8030229-2021-01645
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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: MULTIPLE PATIENT RECEIVER'S ORG'S; MULTIPLE PATIENT RECEIVERS ORGS; MULTIPLE TELEMETER(S); MULTIPLE TELEMETERY TRANSMITTERS