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 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that they are having communication dropouts, and an error light on the multiple patient receiver (org) that will not turn off.This would affect patient monitoring of telemetry transmitters (teles) on the central nurse's station (cns).It is unclear if there was a communication loss error displayed when the communication dropouts occurred.They rebooted it, but issue persists.It happened last week, but the reboot fixed it that time.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.D10 concomitant medical device.Attempt #1 06/15/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the patient and additional device information as requested.Central nurse's station.Telemetry transmitter(s).

Event Description

The biomedical engineer (bme) reported that they are having communication dropouts, and an error light on the multiple patient receiver (org) that will not turn off.This would affect patient monitoring of telemetry transmitters (teles) on the central nurse's station (cns).It is unclear if there was a communication loss error displayed when the communication dropouts occurred.They rebooted it, but issue persists.It happened last week, but the reboot fixed it that time.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was experiencing communication dropouts with the telemetry transmitters monitored at the central nurse's station (cns).It was not clear if the cns displayed a comm loss error at the time.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was experiencing communication dropouts with the telemetry transmitters monitored at the central nurse's station (cns).Additionally, an error light on the org would not turn off.It was not clear if the cns displayed a comm loss error at the time.No patient harm was reported.Investigation summary: they rebooted the device, but the issue persisted.It happened the previous week, and a reboot fixed it that time.Nihon kohden (nk) received the device on 06/19/2023.Nk repair center evaluated the unit on 06/23/2023 and duplicated the complaint.No physical damage or fluid intrusion was observed.The unit was initialized to factory settings to repair it.The device was returned to the customer on (b)(6) 2023.The issue recurred on (b)(6) 2023 under ticket (b)(4).The complaint device was returned to nk again on 10/19/2023.Nk repair center (rc) evaluated the unit on 10/24/2023 and duplicated the error led flashing.No physical damage or fluid intrusion was observed.Nk rc initialized the unit and checked the transmissions and reception.No problems were observed during the extended testing period.A definitive root cause could not be determined since communication loss was not observed during the second evaluation.Possible causes may include incompatible software versions between the org and cns, or user error with the org's network settings such as an 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 system 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 an ungraceful shutdown, power outages, or user error while upgrading the software.A review of the complaint device's serial number does not show recurrence of the issue since the unit was sent back to the customer for ticket (b)(4).A review of the customer's complaint history shows 1 similar complaint for another org under ticket (b)(4) in which the complaint was duplicated during evaluation and the device was repaired by initializing the unit.A definitive root cause could not be determined for ticket (b)(4), but possible causes may be the same as described above.A review of the customer's complaint history showed no trend that may suggest a manufacturing defect.Nk will continue to monitor and trend similar complaints.Central nurse's station: model: ni sn: ni.Telemetry transmitters: model: ni sn: ni.

• 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: 17307598
• MDR Text Key: 319192827
• Report Number: 8030229-2023-03655
• 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: 12/14/2023

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: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• 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.; TELEMETRY TRANSMITTER(S).; TELEMETRY TRANSMITTERS.