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 10/31/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing in communication loss, and that it had an error light illuminated on it.They rebooted the unit, but the issue persisted.They had a spare org, so tech support (ts) assisted them with replacing it with that one.While doing so, they found one of the receiver cards out of the eight had failed.Ts assisted them with replacing the failed receiver card.After doing that, they were able to monitor all receiver cards on the replacement org.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing in communication loss, and that it had an error light illuminated on it.They rebooted the unit, but the issue persisted.They had a spare org, so tech support (ts) assisted them with replacing it with that one.While doing so, they found one of the receiver cards out of the eight had failed.Ts assisted them with replacing the failed receiver card.After doing that, they were able to monitor all receiver cards on the replacement org.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: ni.Sn: ni.Telemetry transmitter(s): model: ni.Sn: ni.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing comm loss, with an error light illuminated on the unit.Rebooting the org did not resolve the issue.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was showing comm loss, with an error light illuminated on the unit.Rebooting the org did not resolve the issue.No patient harm was reported.Investigation summary: the reported device was sent into nihon kohden (nk) for repair, which was received on (b)(6) 2023.Nk repair center (rc) completed the evaluation on (b)(6) 2023 and was able to duplicate the complaint.No physical damage or fluid intrusion was observed.The unit was initialized to repair the device.The receivers' signal and networking function were checked, and the unit operated to manufacturer's specifications.A definitive root cause for the communication loss could not be determined from the device evaluation.Possible causes may include incompatible software versions between the org and cns, or user error with the org's network settings, such as the incorrect network communication protocol.The customer should ensure devices within the patient monitoring network are on compatible software versions and on the same net protocol setting.A possible cause of the error light may be related to the backup ram which stores the system's settings.The org-9100 service manual recommends initialization to troubleshoot error lights related to the backup ram.Memory processing components may become corrupt due to ungraceful shutdowns, power outages, or user error while upgrading software.A definitive root cause for the receiver card not showing in the host network could not be determined since we did not see an issue with the receivers during the evaluation.Possible causes may include loose insertion of the receiver card, incorrect settings, or environmental interference.There has not been a recurrence of these issues since the repaired device was returned to the customer on (b)(6) 2023.Review of the complaint device's serial number does not show other complaints.Review of the customer's complaint history shows 2 similar complaints under tickets (b)(4) and (b)(4) for another org in which the device was returned to nk and we duplicated the complaint, but a definitive cause could not be determined from evaluation.Possible causes of the similar tickets from this customer may be the same as described above.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 attempt #1 11/06/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/16/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 11/22/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: central nurse's station: model: ni sn: ni telemetry transmitters: model: ni sn: ni 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.

• 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: 18243802
• MDR Text Key: 330564917
• Report Number: 8030229-2023-03887
• 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: 01/04/2024

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: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2020
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; ZM TRANSMITTER(S); ZM TRANSMITTERS