MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number	ORG-9100A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their multiple patient receiver (org) is experiencing constant communication loss.The customer did not want to troubleshoot and will be sending this unit in for an exchange.No harm or injury occurred.
Additional Manufacturer Narrative
The customer reported that their multiple patient receiver (org) is experiencing constant communication loss.The customer did not want to troubleshoot and will be sending this unit in for an exchange.No harm or injury occurred.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.
Additional Manufacturer Narrative
Complaint details: the customer reported that their multiple patient receiver (org) is experiencing constant communication loss.The customer did not want to troubleshoot and will be sending this unit in for an exchange.No harm or injury occurred.Complaint investigation: the org in question was returned and evaluated by nk repair center.The issue of intermittent communication loss was not able to be duplicated after 24 hours of extended testing.The issue is unlikely to be a result of a device malfunction.Communication loss indicates that the org is unable to communicate with nk cns's and rns's.Possible root causes include ethernet cable failure due to physical damage or issues with the customer's network as the customer reported that communication loss was occurring daily on the returned org and testing did not reveal any issues.The customer also did not want to troubleshoot the issue.It is possible that the issue could have been resolved by troubleshooting the customer's configuration.As the returned device was found to be in good working condition, 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 h7 h9 the following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt #1 02/24/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/03/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/102022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional information: b4 d9 g3 g6 h2 h3 h6 h10.
Event or Problem Description
The customer reported that their multiple patient receiver (org) is experiencing constant communication loss.The customer did not want to troubleshoot and will be sending this unit in for an exchange.No harm or injury occurred.

• Brand Name: ORG-9100A
• Common Device Name: 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: 13727040
• Report Number: 8030229-2022-02587
• Device Sequence Number: 6055162
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown