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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NKUS LAB CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION
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NKUS LAB CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION Back to Search Results
Model Number EDNS-9001
Device Problems Smoking (1585); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reports that the monitor/screen for the prefense started to smoke.Customer shut the unit down and disconnected the monitor from the main unit.No patient harm was reported.One patient was being monitored on the device, additionally; they were also monitored on two other nihon kohden devices.The unit is being returned for evaluation and repair.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 reports that the monitor/screen for the prefense started to smoke.Customer shut the unit down and disconnected the monitor from the main unit.No patient harm was reported.One patient was being monitored on the device, additionally; they were also monitored on two other nihon kohden devices.
 
Manufacturer Narrative
The customer reported that the monitor/screen for the prefense started to smoke.The customer shut the unit down and disconnected the monitor from the main unit.No patient harm was reported.One patient was being monitored on the device and was also monitored on two other nihon kohden devices.The unit was returned for evaluation and repair, however it was later determined that the monitor/screen was not manufactured by nihon kohden, therefore no evaluation or repair was performed on the unit.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
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Brand Name
CENTRAL MONITORING SYSTEM
Type of Device
CENTRAL MONITORING STATION
Manufacturer (Section D)
NKUS LAB
14 brunsen
attn: shama mooman
irvine CA 92618
Manufacturer (Section G)
NKUS LAB
14 brunsen
attn: susan shadley
irvine CA 92618
Manufacturer Contact
shama mooman
14 bunsen
irvine, CA 92618
9492687488
MDR Report Key6244711
MDR Text Key65053556
Report Number2032233-2017-00002
Device Sequence Number1
Product Code DRG
UDI-Device Identifier00851725007023
UDI-Public00851725007023
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEDNS-9001
Device Catalogue NumberEDNS-9001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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