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

Model Number EDNS-9001

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 206150591
• Report Number: 2032233-2020-00101
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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