• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NKUS LAB CENTRAL MONITORING SYSTEM CENTRAL MONITORING STATION Back to Search Results
Model Number EDNS-9001
Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2021
Event Type  malfunction  
Manufacturer Narrative
Nihon kohden technician advised the customer that this product line is no longer supported and has reached its end-of-life expectancy. 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 customer reported that the prefense monitor's display was blue and displayed a message that the unit will shut down in order to not damage the unit and when the customer attempted to power it back on, the unit would not power on. No patient harm was reported. Nihon kohden technician advised the customer that this product line is no longer supported and has reached its end of life expectancy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCENTRAL MONITORING SYSTEM
Type of DeviceCENTRAL MONITORING STATION
Manufacturer (Section D)
NKUS LAB
attn: shama mooman
14 bunsen
irvine CA 92618
MDR Report Key12443803
MDR Text Key282229207
Report Number8030229-2021-01643
Device Sequence Number1
Product Code DRG
UDI-Device Identifier00851725007023
UDI-Public00851725007023
Combination Product (y/n)N
PMA/PMN Number
K102106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEDNS-9001
Device Catalogue NumberEDNS-9001
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2021
Is This a Reprocessed and Reused Single-Use Device? No

-
-