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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
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2016
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reports that when trying to hook the repaired device back up, the device does not connect properly with the kvm switch.The local monitor was able to operate properly, however the remote monitor did not.The device powers off with movement.The device was returned for evaluation and repair.The issue could not be duplicated.The unit powered on with no issue.The power cord was moved around to test for a defective power connector; however, there was no issue found.It should be noted that this is not a mobile unit and the customer should not be moving the unit around.
 
Event Description
The biomedical engineer reports that when trying to hook the repaired device back up, the device does not connect properly with the kvm switch.The local monitor was able to operate properly, however the remote monitor did not.The device powers off with movement.
 
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Brand Name
CENTRAL MONITORING SYSTEM
Type of Device
CENTRAL MONITORING STATION
Manufacturer (Section D)
NKUS LAB
14 brunsen
attn: susan shadley
irvine CA 92618
Manufacturer (Section G)
NKUS LAB
14 brunsen
attn: susan shadley
irvine CA 92618
Manufacturer Contact
susan shadley
14 bunsen
irvine, CA 92618
9492687708
MDR Report Key5874284
MDR Text Key52080164
Report Number2032233-2016-00387
Device Sequence Number1
Product Code DRG
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
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2011
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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