MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) was having intermittent signal loss on multiple transmitters.No patient harm was reported.Bme is sending the device into nihon kohden for evaluation and repair.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.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was having intermittent signal loss on multiple transmitters.No patient harm was reported.The bme is sending the device into nihon kohden for evaluation and repair.

Manufacturer Narrative

Complaint summary: on 11/15/2023, the biomed reported an intermittent signal loss on just one org (model: org-9110a, serial number: (b)(6) receiver cards with multiple transmitters.The customer tested several of the org receiver cards, as well as tested rssi values and noise.All the values were correct.The customer isolated the signal loss to this one org they would like to send the unit in for repair.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.Investigation summary: the reported issue was duplicated and confirmed.Repair center found during evaluation that ch 4, 5, 6, and 7 were noisy and recommended changing the receiver cards for these channels.A definitive root cause could not be determined.But based on the available information, the most probable root cause was contributed to defective receiver cards causing signal loss.The device was repaired, all malfunctioning parts were replaced, and the unit was shipped back to the customer successfully.A serial number review of the reported device (model: org-9110a, serial number: 333) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Attempt # 1: 11/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 11/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 12/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was having intermittent signal loss on multiple transmitters.No patient harm was reported.The bme is sending the device into nihon kohden for evaluation and repair.

• 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: 18296745
• MDR Text Key: 330133727
• Report Number: 8030229-2023-03913
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2012
• 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