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

Model Number	EDNS-9001
Medical Device Problem Codes	Power Problem (3010); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that the prefense monitoring system showed no signs of activity.The led on the display did not light up.The called was uninterested in troubleshooting the issue further and decided to replace the prefense with another device.The customer was told that we no longer support the prefense and cannot be repaired.This unit is used to monitor telemetry transmitters.No patient harm reported.
Additional Manufacturer Narrative
The customer stated that the prefense monitoring system showed no signs of activity.The led on the display did not light up.The called was uninterested in troubleshooting the issue further and decided to replace the prefense with another device.The customer was told that we no longer support the prefense and cannot be repaired.This unit is used to monitor telemetry transmitters.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.Concomitant medical device: the telemetry transmitters were being used in conjunction with the prefense but no model or serial numbers were provided.
Additional Manufacturer Narrative
Details of complaint: the customer stated that the prefense central station (edns) showed no signs of activity, and the activity led was not lit.The customer was advised that nihon kohden (nk) no longer supports the edns, and it cannot be repaired.The unit was monitoring telemetry transmitters.No patient harm or injury was reported.Investigation summary: the customer was not interested in troubleshooting/investigating the issue and had decided to just replace the edns with an rns.The device had been in service since (b)(6) 2012.A review of the history of the serial number identified no other issues reported on the device.Based on the available information, a definitive root cause could not be identified.Possible causes of the issue are improper shutdown, ups failure, a loose or damaged power cable, and wear and tear of the device components such as the power supply and power brick.
Event or Problem Description
The customer stated that the prefense monitoring system showed no signs of activity.The led on the display did not light up.The called was uninterested in troubleshooting the issue further and decided to replace the prefense with another device.The customer was told that we no longer support the prefense and cannot be repaired.This unit is used to monitor telemetry transmitters.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: 10034205
• Report Number: 2032233-2020-00253
• Device Sequence Number: 16847265
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/01/2023

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: 04/14/2020
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2011
• 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: TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS
• Patient Sex: Unknown