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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 Overheating of Device (1437); Device Inoperable (1663); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the prefense monitor was overheating and shut down due to a bad cpu fan. They were provided with the part number for a whole unit replacement, since individual parts are not available for this model. No patient harm was reported.
 
Event Description
The customer reported that the prefense monitor was overheating and shut down due to a bad cpu fan.
 
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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 Key7249636
MDR Text Key99798211
Report Number2032233-2018-00038
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,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEDNS-9001
Device Catalogue NumberEDNS-9001
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2019
Distributor Facility Aware Date07/24/2019
Device Age81 MO
Event Location No Information
Date Report to Manufacturer07/24/2019
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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