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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 Failure to Power Up (1476); Device Stops Intermittently (1599)
Patient Problem No Information (3190)
Event Date 09/08/2016
Event Type  malfunction  
Manufacturer Narrative
Customer reports that the prefense device boots up and turns off right away.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
Customer reports that the prefense device boots up and turns off right away.
 
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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 Key6013229
MDR Text Key57361002
Report Number2032233-2016-00514
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 09/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/08/2016
Initial Date FDA Received10/09/2016
Was Device Evaluated by Manufacturer? No
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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