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

Model Number	EDNS-9001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their prefense monitor is not any displaying any etco2 data.No harm or injury was reported.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.
Event or Problem Description
The customer reported that their prefense monitor is not any displaying any etco2 data.No harm or injury was reported.
Event or Problem Description
The customer reported that the prefense (edns) monitor was not displaying etco2 data.No harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the prefense (edns) monitor was not displaying etco2 data.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event and no troubleshooting was performed, the reported issue could not be confirmed.As such, a root cause cannot be determined.Due to the age of the complaint, additional information is unlikely to be available.No further issues have been reported.No similar issues were discovered relating to etco2 and this prefense monitor.Possible root causes may be related to improper set-up, incorrect settings, a damaged cable, or a malfunctioning co2 monitor.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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 b7 d10 attempt #1 09/10/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/17/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 09/24/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

• 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; attn: shama mooman; 14 bunsen; 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: 12530617
• Report Number: 8030229-2021-01719
• Device Sequence Number: 19063469
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,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: 08/29/2021
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2011
• 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: NI.; NI.
• Patient Sex: Unknown