• 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 No Display/Image (1183); Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCENTRAL MONITORING SYSTEM
Type of DeviceCENTRAL MONITORING STATION
Manufacturer (Section D)
NKUS LAB
14 bunsen
attn: shama mooman
irvine, ca
Manufacturer (Section G)
NKUS LAB
14 bunsen
attn: shama mooman
irvine, ca
Manufacturer Contact
shama mooman
14 bunsen
irvine, ca 
2687488
MDR Report Key9742256
MDR Text Key206150591
Report Number2032233-2020-00101
Device Sequence Number1
Product Code DRG
UDI-Device Identifier00851725007023
UDI-Public00851725007023
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-