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

Model Number EDNS-9001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that on the prefense (edns) there were discrepancies in the historical vital signs printed out for the same patient for the same time frame when printed in intervals.The print out at 10 am is different from the print out at 6pm for the patient vitals for the same time frame.This device is at end of life.No patient harm reported.Nihon kohden continues to investigate the reported event.Attempt #1 01/13/2021: emailed customer via microsoft outlook for all items under the no information section.They provided response of unknown.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 02/02/2021: emailed the person that manages information via microsoft outlook.They are out of office and the other person was not able to provide the information, so will have to provide this with the supplement.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 01/13/2021: emailed customer via microsoft outlook for the information.They provided response of unknown.

Event Description

The biomedical engineer (bme) reported that on the prefense (edns) there were discrepancies in the historical vital signs printed out for the same patient for the same time frame when printed in intervals.The print out at 10 am is different from the print out at 6pm for the patient vitals for the same time frame.This device is at end of life.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported there were discrepancies in the historical data printed out for the same patient at the same time frame when printed in intervals on the prefense (edns) monitor.The printout at 10:00am was different than the printout at 6:00pm for those patient vitals within the same time frame.The device was at its end of life.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer reported troubleshooting was performed and that they would monitor the prefense.Troubleshooting details were not provided.Due to the age of the complaint, additional information is unlikely to be available.The system was installed in 05/2013 and has since been sunsetted.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.As the customer attempted to troubleshoot the issue and has not reported any issues since, it is likely they were able to resolve the issue through troubleshooting.Possible causes may be related to use error, incorrect settings, or workflow issues.The following fields contains no information (ni), as an attempts to obtain information was made, but not provided.Attempt #1 01/13/2021 emailed customer via microsoft outlook for all items under the no information section.The customer reponded that the requested information was unknown.

Event Description

The biomedical engineer (bme) reported there were discrepancies in the historical data printed out for the same patient at the same time frame when printed in intervals on the prefense (edns) monitor.The printout at 10:00am was different than the printout at 6:00pm for those patient vitals within the same time frame.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; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; 14 bunsen; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 11290045
• MDR Text Key: 242389548
• Report Number: 2032233-2020-00043
• 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

• 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
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2019
• 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