MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problem Communication or Transmission Problem (2896)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that six central nurse's stations (cns(s)) lost communication with all gz transmitters in the tele-monitoring room, first for 30 seconds, then for a second time for 20 seconds.The customer stated that the wi-fi did not go down during the event.Nihon kohden technical support (nk ts) requested log files for the cns(s) and escalated the issue to the client it services team (cits).Cits is investigating the enterprise gateway and ran a packet capture and debug logs.Cits monitored the issue for the next three days while running the programs.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 device information: the following devices were used in conjunction with the cns.Gz transmitters: model #: ni, sn #: ni, approximate age of the device: ni, device manufacturer date: ni.

Event Description

The customer reported that six central nurse's stations (cns(s)) lost communication with all gz transmitters in the tele-monitoring room, first for 30 seconds, then for a second time for 20 seconds.The customer stated that the wi-fi did not go down during the event.

Manufacturer Narrative

Details of complaint: the customer reported that six central nurse's stations (cnss) lost communication with all gz transmitters in the telemonitoring room.First for 30 seconds, then again for 20 seconds.The customer stated that the wi-fi did not go down during the event.Nihon kohden technical support (nk ts) requested log files for the cns devices and escalated the issue to the client it services team (cits).Cits investigated the enterprise gateway and ran a packet capture and debug logs.No patient harm was reported.Service requested / performed: troubleshooting: an irc was initiated to further the investigation and the investigation result was documented as a3-211103_final-eg.When investigating the cns logs, it was found that the communication loss happened simultaneously on the reported date.But the cns devices had performed as intended.When the log of qp-988p server was investigated which revealed that the "unified gateway service" was abnormally rebooted at 13:44:28 on november 27, 2019.This reboot caused the abrupt communication loss.Investigation summary: the issue was found to be caused due to the gateway server reboot.The possible causes of hl7 server issues are limited to customer network/server as well as customer user specifications like data queuing, ungraceful exits, incorrect customer flows, permission issues, etc.These issues vary from internal network settings of the customer-to-customer use and are not related to malfunctioning or deviation from performance of nk devices.The reported issue does not require further investigation through capa process since hl7 issues are caused due to customer network/server malfunction.This does not suggest nk device deficiency/malfunction.The following fields are not applicable (na) to the mdr report: b2 b6 b7 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional device information: the following devices were used in conjunction with the cns.Gz transmitters model #: ni.Sn #: ni approximate age of the device: ni.Device manufacturer date: ni.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The customer reported that six central nurse's stations (cns(s)) lost communication with all gz transmitters in the tele-monitoring room, first for 30 seconds, then for a second time for 20 seconds.The customer stated that the wi-fi did not go down during the event.

• Brand Name: CNS-6801A
• Type of Device: CENTRAL MONITOR SYSTEM
• 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: 9533644
• MDR Text Key: 194126862
• Report Number: 8030229-2019-00748
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• 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: 12/30/2019,02/28/2022

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: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2019
• Distributor Facility Aware Date: 12/03/2019
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• 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: GZ TRANSMITTERS; GZ TRANSMITTERS