NEUROCOM EQUITEST NCM-SMEQ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-07 for NEUROCOM EQUITEST NCM-SMEQ manufactured by Natus Medical Incorporated.

MAUDE Entry Details

Report Number3018859-2019-00009
MDR Report Key9293608
Report SourceUSER FACILITY
Date Received2019-11-07
Date of Report2019-10-24
Date of Event2019-10-24
Date Mfgr Received2019-10-24
Date Added to Maude2019-11-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAMES FITZGERALD
Manufacturer Street5900 1ST AVENUE S.
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone2062685173
Manufacturer G1NATUS MEDICAL INCORPORATED
Manufacturer Street5900 1ST AVENUE S.
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal Code98108
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEUROCOM EQUITEST
Generic NameSMART EQUITEST
Product CodeKHX
Date Received2019-11-07
Model NumberNCM-SMEQ
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 1ST AVENUE S SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-07

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