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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 NameCENTRAL MONITORING SYSTEM
Type of DeviceCENTRAL 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
0 Patients were Involved in the Event:
Date FDA Received10/09/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2016
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

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