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 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) was going into constant communication loss.The bme thought they resolved the issue but it reoccured so they removed the unit and swapped it with a spare and would like to send it to nihon kohden for evaluation.No patient harm was reported.There is a second event reported on mdr 03979 300351748 for this same serial number (b)(6).And issue.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.Repair /service the device was received to nihon kohden repair center was tested and it could not be duplicated for the communication loss error message.However, nkrc evaluation found the unit has antenna connection problem.Nkrc realigned both antenna connections, checked network connection, installed udi on the unit, tested the device per the service manual for 24 hours of extended testing and device operated to manufacture's specifications.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 the following device(s) was used in conjunction with the org: zm transmitters: model #: zm-531pa serial #: (b)(6).Device manufacturer date: 12/13/2016 unique identifier (udi) #: 04931921115107 returned to nihon kohden: no model #: zm-531pa serial #: (b)(6).Device manufacturer date: 12/20/2021 unique identifier (udi) #: (b)(4).Returned to nihon kohden:.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was going into constant communication loss.The bme thought they resolved the issue but it reoccurred so they removed the unit and swapped it with a spare and would like to send it into nihon kohden for evaluation.No patient harm was reported.

Manufacturer Narrative

Complaint summary: biomed reports the multiple patient receiver (org) is having constant communication loss issues over the weekend even after troubleshooting by rebooting the unit the issue reappeared.Biomed request to send this unit in for evaluation.Investigation summary: nihon kohden repair center evaluated the device and the complaint could not be duplicated, however they found that the antenna had a connection problem.No physical damage or fluid intrusion observed.The antennas were re-aligned, and the network connection was checked.The unit was tested and operated to manufacturer specifications.Based on the device evaluation, the cause of the issue was most likely loose connection of the receiving antenna which may have occurred through user error with device set-up.The org operator's manual and service manual states to check the connection conditions of the org's antennas and network connectors as part of periodic inspection.The device was returned to the customer on 12/21/2023.Review of the complaint device's serial number does not show further recurrence.Nk will continue to monitor and trend similar complaints.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: no reply received.Attempt # 2: 12/19/2023 emailed the customer via microsoft outlook for patient information: reply was received and the biomed reported they do not have and cannot give out the patient information.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the org: zm transmitters: model #: zm-531pa serial #: (b)(6_ device manufacturer date: 12/13/2016 unique identifier (udi) #: (b)(4) returned to nihon kohden: no model #: zm-531pa serial #: (b)(6) device manufacturer date: 12/20/2021 unique identifier (udi) #: 04931921115107 returned to nihon kohden: no additional information: b4: date of this report e1: reporter name and address g3: date received by manufacturer, initial date received by manufacturer was 12/04/2023.Additional information date received by manufacturer for supplemental mdr is 03/07/2024 g6: type of report h2: if follow-up, what type? h3: device evaluated by manufacturer? h6: adverse event problem codes.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was going into constant communication loss.The bme thought they resolved the issue but it reoccurred so they removed the unit and swapped it with a spare and would like to send it into nihon kohden for evaluation.No patient harm was reported.

• 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: 18415212
• MDR Text Key: 331580395
• Report Number: 8030229-2023-03970
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• 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: ZM-531PA; ZM-531PA