ERGOJUST CART - VIDEO EXTENSION IP-EC-DT-CART-EXP 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 2019-07-10 for ERGOJUST CART - VIDEO EXTENSION IP-EC-DT-CART-EXP N/A manufactured by Natus Medical Inc. Dba Excle-tech Ltd (xltek).

MAUDE Entry Details

• Report Number: 9612330-2019-00005
• MDR Report Key: 8778440
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-07-10
• Date of Report: 2019-06-28
• Date of Event: 2019-06-20
• Date Mfgr Received: 2019-06-28
• Date Added to Maude: 2019-07-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR SANJAY MEHTA
• Manufacturer Street: 2568 BRISTOL CIRCLE
• Manufacturer City: OAKVILLE, ONTARIO L6H5S1
• Manufacturer Country: CA
• Manufacturer Postal: L6H5S1
• Manufacturer G1: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK)
• Manufacturer Street: 2568 BRISTOL CIRCLE
• Manufacturer City: OAKVILLE, L6H5S1
• Manufacturer Country: CA
• Manufacturer Postal Code: L6H5S1
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ERGOJUST CART - VIDEO EXTENSION
• Generic Name: ELECTROENCEPHALOGRAPH
• Product Code: GWQ
• Date Received: 2019-07-10
• Model Number: IP-EC-DT-CART-EXP
• Catalog Number: N/A
• Lot Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)
• Manufacturer Address: 2568 BRISTOL CIRCLE OAKVILLE, L6H 5S1 CA L6H 5S1

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-10