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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

The customer reported that the org is displaying communication loss (comm loss).There was no patient injury reported.

Manufacturer Narrative

According to the customer, they have to reboot the unit in order to correct the comm loss message.The issue happens randomly, but once they reboot the org, the issue goes away; however, the issue returns a few days later.The issue happens 1-2 times a week.Technical support (ts) suggested for the customer to check the ports and switch; however, the customer was not on-site.The customer will have the tech reach out to troubleshoot the issue.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 customer reported that the org is displaying communication loss (comm loss).According to the customer, they have to reboot the unit in order to correct the comm loss message.The issue happens randomly, but once they reboot the org, the issue goes away; however, the issue returns a few days later.The issue happens 1-2 times a week.Technical support (ts) suggested for the customer to check the ports and swich; however, the customer was not on-site.The customer will have the tech reach out to troubleshoot the issue.There was no patient injury reported.Investigation summary: the customer was unresponsive to nk tech support attempts at reaching out and troubleshooting the issue of communication loss.As such, root cause cannot be determined.No further issues were reported in the following three months.It is likely that the issue of communication loss was resolved without the assistance of nka representatives.Communication loss occurs when the org is not able to communicate with cn's or rns's on the customer network.Ethernet cable damage, defective customer network switches, and instability in the customer network are known causes of communication loss on the customer's side.The risk for patient harm is mitigated in the design of the central monitoring stations as it is designed to notify clinicians in the case that communication occurs with org devices.As the cause of the issue cannot be confirmed and the customer was unresponsive to follow up attempts, a capa is not warranted.The following fields are not applicable (na) to this report: b2, d4 lot # & expiration date, d6a & d6b, d7b, f1 - f14, g4 device bla number, g5, g7, h2, h7, h9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Manufacturer references # (b)(4) - 124875 follow up 001.

Event Description

The customer reported that the org is displaying communication loss (comm loss).There was no patient injury reported.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12965451
• MDR Text Key: 283271959
• Report Number: 8030229-2021-02104
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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
• 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
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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