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 12/07/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported on (b)(6) 2023 that the central nurse's station (cns) was showing communication loss for a few devices and were able to determine that the devices that show communication loss are telemetry transmitters all on the same multiple patient receiver (org).They did a full reboot of the org and reseated the ethernet cable.They will monitor it and see if it happens again.On (b)(6) 2023, the customer stated that this is still happening and would like to have this unit sent in for repair.They received loaner org to use in the meantime.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported on (b)(6) 2023 that the central nurse's station (cns) was showing communication loss for a few devices and were able to determine that the devices that show communication loss are telemetry transmitters all on the same multiple patient receiver (org).They did a full reboot of the org and reseated the ethernet cable.They will monitor it and see if it happens again.On (b)(6) 2023, the customer stated that this is still happening and would like to have this unit sent in for repair.They received loaner org to use in the meantime.No patient harm was 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.Central nurse's station model: cns-6201a.Sn: (b)(6).Device manufacturer date: 12/09/2014.Unique identifier (udi) #: (b)(6).Returned to nihon kohden: not returned.

• 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: 18460674
• MDR Text Key: 332735162
• Report Number: 8030229-2024-04030
• Device Sequence Number: 1
• Product Code: DRG
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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-6201A SN (B)(6); ZM TELEMETRY TRANSMITTER(S)