• 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 Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the unit overheated and shut down. Customer was advised to clean and blow out the dust from the unit. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the unit overheated and shut down.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCENTRAL MONITORING SYSTEM
Type of DeviceCENTRAL MONITORING STATION
Manufacturer (Section D)
NKUS LAB
5 jenner, suite 180
attn: shama mooman
irvine CA 92618
Manufacturer (Section G)
NKUS LAB
5 jenner, suite 180
attn: shama mooman
irvine CA 92618
Manufacturer Contact
shama mooman
5 jenner, suite 180
irvine, CA 92618
9492687708
MDR Report Key6715036
MDR Text Key80097751
Report Number2032233-2017-00236
Device Sequence Number1
Product Code DRG
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 07/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2017
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? No
Event Location No Information
Date Manufacturer Received07/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-