CONNEX BRAIN MONITOR BREAKOUT BOX 012378 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-14 for CONNEX BRAIN MONITOR BREAKOUT BOX 012378 N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).

MAUDE Entry Details

Report Number9612330-2019-00004
MDR Report Key8699206
Report SourceHEALTH PROFESSIONAL
Date Received2019-06-14
Date of Report2019-05-16
Date of Event2019-05-16
Date Mfgr Received2019-05-16
Date Added to Maude2019-06-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR SANJAY MEHTA
Manufacturer Street2568 BRISTOL CIRCLE
Manufacturer CityOAKVILLE, ONTARIO L6H5S1
Manufacturer CountryCA
Manufacturer PostalL6H5S1
Manufacturer G1NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK)
Manufacturer Street2568 BRISTOL CIRCLE
Manufacturer CityOAKVILLE, L6H5S1
Manufacturer CountryCA
Manufacturer Postal CodeL6H5S1
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONNEX BRAIN MONITOR BREAKOUT BOX
Generic NameELECTROENCEPHALOGRAPH
Product CodeGWQ
Date Received2019-06-14
Returned To Mfg2019-07-04
Model Number012378
Catalog NumberN/A
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)
Manufacturer Address2568 BRISTOL CIRCLE OAKVILLE, L6H 5S1 CA L6H 5S1


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.