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 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) biomed reported that the multiple patient receiver (org) was giving intermittent "comm loss" & "registered bed not ready error" messages at the central nurses station (cns) for all the transmitters.Technical support (ts) had them swap the network cable from another org in the closet, but the issue persisted.No reports of patient harm.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.D10 concomitant medical device: the following devices were used in conjunction with the org: cns: cns-6801.Model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 05/04/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was giving intermittent "comm loss" & "registered bed not ready error" messages at the central nurses station (cns) for all the transmitters.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) gave intermittent "comm loss" & "registered bed not ready error" messages at the central nurse's station (cns) for all the transmitters.Technical support (ts) had them swap the network cable from another org in the closet, but the issue persisted.No reports of patient harm.Investigation summary: nk repair center (rc) evaluated the device on 06/23/2023 and could not duplicate the complaint.The unit was initialized and then evaluated again on 06/28/2023.The complaint could not be duplicated again.Nk rc performed a complete functional check and did not find a problem with the complaint device.A review of the complaint device's serial number shows 2 previous complaints, both with similar issues, under ticket (b)(4) and ticket (b)(4).In the previous complaints, the device was returned for evaluation, but the complaint could not be duplicated both times.A review of the customer site shows that they had multiple org units installed in (b)(6) 2013.Due to the time passed since installation, it is possible that some of the cables associated with their org systems may have become loose or damaged through wear-and-tear.Possible issues that may cause both the "communication loss" and "registered bed not ready" error messages include problems with the customer's local network.A previous investigation by nkc in regards to the "registered bed not ready" error message revealed that it could occur when there is a connection established, but only partial information can be communicated due to poor network conditions, use of inadequate network hardware, or issues with the antenna system at the customer's site.Communication problems may arise as a result of loose or damaged network or antenna/coaxial cables, which could be due to user mishandling or wear-and-tear over time.Additionally, the org operator's manual recommends using different network cable types based on the number of orgs that the customer wants to connect to their network.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: 05/11/2023 emailed biomed for the patient's information and concomitant medical device information.No reponse was received.Attemp #2: 05/15/2023 emailed biomed for the patient's information and and concomitant medical device information.They responded that the patient's information were unknown and would try to retrieve the devices connected to the org.Attempt #3: 05/24/2023 emailed biomed for the concomitant medical device information.They responded with the serial number for the cns but could not retrieve the serial numbers from the transmitters.D10 concomitant medical device: the following devices were used in conjunction with the org: cns: (b)(4).Model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 05/04/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was giving intermittent "comm loss" & "registered bed not ready error" messages at the central nurses station (cns) for all the transmitters.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: 17053076
• MDR Text Key: 317645136
• Report Number: 8030229-2023-03565
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 08/31/2023
• 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: CNS.; CNS.; ZM TRANSMITTERS.; ZM TRANSMITTERS.