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

Model Number EDNS-9001

Device Problems Output Problem (3005); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 245091414
• Report Number: 2032233-2020-00121
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ORG.; TELEMETRY TRANSMITTERS.; TELEMETRY TRANSMITTERS.