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 12/20/2023

Event Type  malfunction  

Event Description

The customer reported that 50% of the patients were missing.There was no patient injury reported.

Manufacturer Narrative

The customer reported that 50% of the patients were missing.The customer's biomed rebooted the org.The customer will send in the unit to be exchanged.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; you can close this out.B6.Attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; you can close this out.B7.Attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; you can close this out.D10.Attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; you can close this out.

Event Description

The customer reported that 50% of the patients were missing.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that 50% of the patients were missing.The customer's biomed rebooted the org.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: the customer later reported that the issue was caused by a broken and loose cable that was connected to the org.Followup with john goforth (technical service account manager) revealed that no further issues have been reported relating to communication loss with the reported device.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.Manufacturer references # (b)(4), follow up 001.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18522807
• MDR Text Key: 332999101
• Report Number: 8030229-2024-04016
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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: 12/20/2023
• 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
• Treatment: CNS; CNS; ZM TRANSMITTERS; ZM TRANSMITTERS