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 11/15/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their multiple patient receiver (org) lost communication with all monitored transmitters.The customer rebooted the org, but the issue persisted.The customer then rebooted the org switch, and all the devices came back up.No harm or injury was reported.Nihon kohden continues to investigate the reported event.Concomitant medical device: the following device was used in conjunction with the org: multiple transmitters: model: ni.Sn: ni.

Event Description

The customer reported that their multiple patient receiver (org) lost communication with all monitored transmitters.

Manufacturer Narrative

Details of complaint: the customer reported that the multiple patient receiver (org) lost communication with all monitored transmitters.The customer rebooted the org, but the issue persisted.The customer then rebooted the org switch, and all the devices came back up.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: nihon kohden tech support (nk ts) was able to identify that the communication loss was occurring due to the customer's network.Nk ts was able to walk the customer through several troubleshooting steps to resolve the issue.As the issue of communication loss was resolved without any rework of nk devices, the cause is unlikely to be related to any malfunction.It was identified that the customer also had non-nk devices connected to the nk network which was causing network congestion.The root cause for communication loss is most likely related to the customer's network.

Event Description

The customer reported that the multiple patient receiver (org) lost communication with all monitored transmitters.

• 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: 10969224
• MDR Text Key: 238986017
• Report Number: 8030229-2020-00739
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• 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: MULTIPLE TRANSMITTERS; MULTIPLE TRANSMITTERS