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 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing communication loss with connected transmitters the bme believes the org has bad receivers because the bme swapped out the transmitters in those sectors and it is still getting intermittent communication loss.No patient harm was reported.The bme is sending the org into nihon kohden repair center.Inspection and service: nihon kohden repair center received the customer's unit and found that front case and rear enclosure has physical damage.Unit was tested and found that all 8 receivers had very bad signals and lots of noise.All 8 receivers version was ad and they are a bad version.Nkrc recommends that the unit needs to have the 8 recievers, front enclosure and rear enclosure replaced or an exchange unit shipped to customer.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 field(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 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 showing communication loss with connected transmitters the bme believes the org has bad receivers because the bme swapped out the transmitters in those sectors and it is still getting intermittent communication loss.No patient harm was reported.The bme is sending the org into nihon kohden repair center.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was showing communication loss with connected transmitters the bme believes the org has bad receivers because the bme swapped out the transmitters in those sectors and it is still getting intermittent communication loss.No patient harm was reported.The bme is sending the org into nihon kohden repair center.Inspection and service: nihon kohden repair center received the customer's unit and found that front case and rear enclosure has physical damage.Unit was tested and found that all 8 receivers had very bad signals and lots of noise.All 8 receivers version was ad and they are a bad version.Nkrc recommends that the unit needs to have the 8 receivers, front enclosure and rear enclosure replaced or an exchange unit shipped to customer.Investigation summary: the cause of the communication loss was bad receivers.A definitive cause for why the receivers had gone bad could not be determined but possible causes include physical damage or fluid intrusion from user mishandling, power issues from site outages or surges which can affect the circuitry of electronic components, environmental issues such as electromagnetic radiation from other devices in the customer's site, or wear-and-tear which depends on the age of the device and frequency of use.A review of the devices' serial number shows that it is 11 years old and has no other complaints.Due to the devices' age, wear-and-tear may be a likely cause or contributing factor to the noise found on the devices' channel receivers.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing communication loss with connected transmitters the bme believes the org has bad receivers because the bme swapped out the transmitters in those sectors and it is still getting intermittent communication loss.No patient harm was reported.The bme is sending the org into nihon kohden repair center.

• 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: 16950876
• MDR Text Key: 315460230
• Report Number: 8030229-2023-03530
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2012
• 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