MAUDE Adverse Event Report: NKUS LAB CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number	EDNS-9001
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the prefense display turned off while monitoring telemetry transmitters.Nihon kohden qa contacted the biomedical engineer (bme) and was told that they resolved the issue by replacing a bad splitter for the remote monitoring displays.As the nurse only provided her first name and no email and as the resolution was provided by the bme, nk used the bme's contact information as the initial reporter.No patient harm 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 nurse reported that the prefense display turned off while monitoring telemetry transmitters.Nihon kohden qa contacted the biomedical engineer and was told that they resolved the issue by replacing a bad splitter for the remote monitoring displays.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the display on the prefense monitor turned off while monitoring telemetry transmitters.The biomedical engineer (bme) later reported that they resolved the issue by replacing a bad splitter for the remote monitoring displays.No patient harm or injury was reported.Investigation summary: after they replaced the bad splitter, the issue was resolved.A review of the history of the serial number identified no similar events.Based on the available information, the most probable cause of the issue is a defective video splitter.The video splitter may fail due to physical damage, and wear and tear from normal use.
Event or Problem Description
The nurse reported that the prefense display turned off while monitoring telemetry transmitters.Nihon kohden qa contacted the biomedical engineer and was told that they resolved the issue by replacing a bad splitter for the remote monitoring displays.No patient harm reported.

• Brand Name: CENTRAL MONITORING SYSTEM
• Common Device Name: CENTRAL MONITORING STATION
• Manufacturer (Section D): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; 14 bunsen; irvine, CA 92618 ; 9492687488
• MDR Report Key: 9742256
• Report Number: 2032233-2020-00101
• Device Sequence Number: 19659965
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 01/29/2020
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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
• Patient Sex: Unknown