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 09/14/2022

Event Type  malfunction  

Event Description

The customer reported that this org is displaying communication loss (comm loss) on all its receiver cards.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this org is displaying communication loss (comm loss) on all its receiver cards.Technical support (ts) had the customer reboot the org and re-seat the network cable, but the issue remained.The customer had a consignment org so ts had the customer put the unit into the spot where the org with the issue was and they were able to find the consignment org in the host table.Ts recommended for the org with the issue to be sent in for repairs.There was no patient injury 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.

Manufacturer Narrative

Details of complaint: the customer reported the org was displaying comm loss with all its receiver cards.Technical support (ts) had the customer reboot the org and reseat the network cable, but the issue remained.They tested a consignment org they had on hand in the same spot the reported org was located, and they were able to find the consignment org in the host table.No patient harm was reported.Investigation summary: the reported device was returned for evaluation.During the evaluation, the reported problem of the org getting comm loss on all its receiver cards could not be duplicated.The device was subjected to extensive testing over the period of a week, but nihon kohden repair center (nk rc) was unable to duplicate the issue.The device was then dispositioned to be returned to the customer.Nk was unable to confirm the reported issue or determine a root cause.However, it is likely the issue was due to a network environmental issue at the facility.Some org issues may be related to user related errors, incorrect settings, installation issues, file or software corruption, battery issues, hardware/component failure issues, the facility's it department issues, or network environmental issues (including power supply or power plug in outlet issues).A review of the device history did not reveal any trends that would contribute to component failure that is related to the design or manufacturing of the device.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.Attempt # 1: 09/28/2022 emailed the customer via microsoft outlook for the requested information in the ni list: no reply was received.Attempt # 2: 10/04/2022 emailed the customer via microsoft outlook for the requested information in the ni list: no reply was received.Attempt # 3: 10/11/2022 emailed the customer via microsoft outlook for the requested information in the ni list: no reply was received.Additional model information: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Zm transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

Event Description

The customer reported the org was displaying comm loss with all its receiver cards.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 ; 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: 15591681
• MDR Text Key: 306610995
• Report Number: 8030229-2022-03115
• 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: 06/29/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2013
• 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