MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9100A

Device Problem Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org failed causing the cns to go into signal loss with the transmitters.The customer indicated that rebooting the org seem to help; however, the issue came back after a short period of time.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The following devices were being used in conjunction with the org: cns (serial number: unknown).Transmitters (serial number: unknown).

Event Description

The customer reported that the org failed causing the cns to go into signal loss with the transmitters.No consequence or impact to the patients were reported.

Event Description

The customer reported that the org failed causing the central nurse's station (cns) to go into signal loss with the transmitters.No consequence or impact to the patients were reported.

Manufacturer Narrative

Details of complaint: the customer reported that the org failed causing the central nurse's station (cns) to go into signal loss with the transmitters.The customer indicated that rebooting the org seem to help; however, the issue came back after a short period of time.No patient harm was reported.Service requested / performed: troubleshooting: nk ts was unable to troubleshoot the issue with the customer.However, the customer thought that a cns software upgrade (from v 1-06 to v 2-40).Would resolve the issue.Investigation summary: the device was not returned for physical evaluation and functional analysis.The customer was provided with instructions on how to upgrade the cns software.It was not explicitly stated by the customer that the issue had been resolved.An historical review of the of the serial number showed there were no further complaints regarding the cns after this ticket, which suggests that the software upgrade may have helped in resolving the issue.Based on the available information, a definitive root cause could not be identified.However, it is possible that the issues experienced by the customer was due to an outdated software version.Per sop07-003, no capa is required as the overall risk rating of the event is medium.Additionally, the root cause was unable to be determined.The quality event does not warrant a corrective action.Without a root cause, the counter measure to prevent recurrence cannot be performed.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: cns: model #: ni, serial #: ni.Transmitters: model #: ni, serial #: ni.

• Brand Name: ORG-9100A
• 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
• MDR Report Key: 8765506
• MDR Text Key: 150388990
• Report Number: 8030229-2019-00280
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/05/2019,10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2019
• Distributor Facility Aware Date: 06/14/2019
• Device Age: 97 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS; CNSTRANSMITTERS; TRANSMITTERS