MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number	EDNS-9001
Medical Device Problem Codes	Output Problem (3005); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the nibp was not saving in the vital signs review which was an issue with historical data saving for the nibp on the prefense telemetry monitoring system.Nihon kohden technical support (tech support) verified that the real time alarms are working normally and that the nibp measurement pop up on the all beds screen.However, when they go to vital signs review, its not there.This is due to the multiple patient receiver (org) issue which affects the telemetry transmitter monitoring.This device is end of life.On 02/09/2021, additional information was provided to us that stated that the customer had additional issues where the unit was not storing any (historical) information.After the reboot, the issue was corrected, except the device was still not saving the nibp.No patient harm reported.Nihon kohden continues to investigate the reported event.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the prefense, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Telemetry transmitters: model: ni, sn: ni.
Event or Problem Description
The customer reported that the nibp was not saving in the vital signs review which was an issue with historical data saving for the nibp on the prefense telemetry monitoring system.Nihon kohden technical support (tech support) verified that the real time alarms are working normally and that the nibp measurement pop up on the all beds screen.However, when they go to vital signs review, its not there.This is due to the multiple patient receiver (org) issue which affects the telemetry transmitter monitoring.This device is end of life.On 02/09/2021, additional information was provided to us that stated that the customer had additional issues where the unit was not storing any (historical) information.After the reboot, the issue was corrected, except the device was still not saving the nibp.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that nibp readings were not saving in the vital signs review (historical data) of the prefense (edns) monitor that was monitoring telemetry transmitters.Technical support (ts) verified that the real time alarms were working normally.This device is at its end of life.No patient harm was reported.Investigation summary: nkc has determined that after 1/1/2021 when the data is transferred from the zm series through the org, the org receiver applies an incorrect date stamp to episodic transmitter data (i.E., arrhythmia recall data, st recall data, and nibp measurement data).This date error is either carried over to the cns/rns or is blocked so that the episodic data is missing depending on the model of the cns/rns.The root cause of this issue is software deficiency.The following fields contains no information (ni), as an attempt to obtain the information was made, but could not be provided.Attempt #1 01/19/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded that this affected their orgs but did not provide patient information.Additional device information: d10: concomitant medical device: the following devices were used in conjunction with the prefense (edns) monitor, but the model and serial number information was listed as no information (ni), as an attempt to obtain the information was made, but could not be provided.Telemetry transmitters: model: ni sn: ni.Org: model: ni sn: ni.
Event or Problem Description
The customer reported that nibp readings were not saving in the vital signs review (historical data) of the prefense (edns) monitor that was monitoring telemetry transmitters.Technical support (ts) verified that the real time alarms were working normally.This device is at its end of life.No patient harm reported.

• Brand Name: CENTRAL MONITORING SYSTEM
• Common Device Name: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 11458003
• Report Number: 2032233-2020-00121
• Device Sequence Number: 17097826
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: EDNS-9001
• Device Catalogue Number: EDNS-9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORG.; TELEMETRY TRANSMITTERS.; TELEMETRY TRANSMITTERS.
• Patient Sex: Unknown