FDA.reportPublic FDA data

MAUDE MDR 8028553

MDR report key
8028553
Report number
9612330-2018-00015
Event key
0
Event type
3
Date of event
2018-02-21
Date received
2018-11-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR SANJAY MEHTA
Address
2568 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H5S CA
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EGOJUST CART - ACCESSORY TO EEG MEDICAL DEVICESELECTROENCEPHALOGRAPHNATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)GWQIP-HD-EC-VIDEO-EXTN/AN/AN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-0101. R

Event Narratives#

N

Patient 1

IN COMPLIANCE WITH 21CFR PART 820.198 - QUALITY SYSTEM REGULATIONS AND NATUS QUALITY MANAGEMENT SYSTEM, WE INITIATED THE INVESTIGATION PRIOR TO THIS COMPLAINT. THE CAUSE OF THE PROBLEM WAS IDENTIFIED AS DEFIENCY IN THE MANUFACTURING PROCESS AT OUR SUPPLIER WHICH RESULTED IN WELD FAILURE. FOLLOWING 21CFR PART 806, NATUS HAS DETERMINED THAT FIELD CORRECTIVE ACTION REQUIRED. THE FCA IS IN PROGRESS TO FIX ALL THE AFFECTED CARTS.

D

Patient 1

NATUS FIELD SERVICE STAFF WAS REPLACING A COMPUTER WHILE HE OBSERVED TWO DEFECTIVE CAMERA MAST ON ERGOJUST CARTS AND FOUND OUT THE WELD WAS CRACKED ON ONE CART. HE REQUESTED FOR REPLACEMENT OF THOSE TWO CARTS.