FDA.reportPublic FDA data

MAUDE MDR 8492924

MDR report key
8492924
Report number
9612330-2019-00002
Event key
0
Event type
3
Date of event
2019-03-25
Date received
2019-04-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1CYCLOPS CARTELECTROENCEPHALOGRAPHNATUS MEDICAL INC. DBA EXCEL-TECH LTD (XLTEK)GWQ10426N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0801. O

Event Narratives#

N

Patient 1

CUSTOMER CONFIRMED THAT THE COMPONENT IS BROKEN DUE TO THE DEVICE STUCK WITH THE STORAGE ROOM DOOR FRAME WHILE BEING MOVED IN TO STORAGE ROOM. A REPLACEMENT COMPONENT IS SENT TO THE CUSTOMER. THIS IS AN ISOLATED INCIDENT. AND THERE WAS NO SAFETY HAZARD TO THE PATIENT OR USER.

D

Patient 1

CART WAS BEING MOVED INTO A STORAGE ROOM BUT HEIGHT OF DOOR FRAME WAS TOO LOW AND VIDEO EXTENSIONS HAD STRUCK THE DOOR FRAME CAUSING THE SLEEVE TO BREAK. NOBODY WAS INJURED.