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 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that there was communication loss across a segment.The multiple patient receiver (org) required to monitor the telemetry transmitter was rebooted and the communication loss message went away.The customer stated that the communication loss was across telemetry devices 90 - 97.No patient harm 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 additional model information: concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni) for the telemetry transmitters, as attempts to obtain information were made but information was not provided.Central nurse's station: model: cns-6201a, sn: (b)(4).Telemetry transmitter: model: ni, sn: ni.

Event Description

The biomedical engineer (bme) reported that there was communication loss across a segment.The multiple patient receiver (org) required to monitor the telemetry transmitter was rebooted and the communication loss message went away.The customer stated that the communication loss was across telemetry devices 90 - 97.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported there was comm loss across one segment of the telemetry transmitters, on devices 90 - 97.The multiple patient receiver (org) was rebooted and the comm loss error message went away.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: as the device was not returned for evaluation, a root cause cannot be determined.The customer called nihon kohden (nk) requesting assistance in changing channels for the telemetry transmitter devices used with the reported org.It is likely that the telemetry devices were using duplicate channels, which would result in communication loss.The customer was educated by nihon kohden tech support (nk ts) on how to change the channels.No further issues were reported with the org relating to communication loss.Root cause is likely related to duplicate channels due to use error or customer education.

Event Description

The biomedical engineer (bme) reported there was comm loss across one segment of the telemetry transmitters, on devices 90 - 97.The multiple patient receiver (org) was rebooted and the comm loss error message went away.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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11043000
• MDR Text Key: 228169729
• Report Number: 8030229-2020-00780
• 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: 11/15/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/19/2020
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2013
• 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-6201A SN (B)(4); CNS-6201A SN (B)(6); TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS