EPIQ DIAGNOSTIC ULTRASOUND SYSTEM EPIQ CVX - 795231

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 2019-08-30 for EPIQ DIAGNOSTIC ULTRASOUND SYSTEM EPIQ CVX - 795231 manufactured by Philips Ultrasound, Inc.

MAUDE Entry Details

• Report Number: 3019216-2019-00063
• MDR Report Key: 8950415
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-08-30
• Date of Report: 2019-07-09
• Date Mfgr Received: 2019-07-09
• Device Manufacturer Date: 2019-04-25
• Date Added to Maude: 2019-08-30
• 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. PAUL CORRIGAN
• Manufacturer Street: 22100 BOTHELL EVERETT HIGHWAY
• Manufacturer City: BOTHELL WA 98021
• Manufacturer Country: US
• Manufacturer Postal: 98021
• Manufacturer Phone: 4254877000
• Manufacturer G1: PHILIPS MEDICAL SYSTEMS
• Manufacturer Street: 3000 MINUTEMAN ROAD
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal Code: 01810
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Generic Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Product Code: IYN
• Date Received: 2019-08-30
• Model Number: EPIQ CVX - 795231
• Lot Number: US419B1523
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS ULTRASOUND, INC
• Manufacturer Address: 22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-30