HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP 1104JP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-29 for HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP 1104JP manufactured by Heartware, Inc..

MAUDE Entry Details

• Report Number: 3007042319-2019-14377
• MDR Report Key: 9391847
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-29
• Date of Report: 2019-11-29
• Date of Event: 2019-09-20
• Date Mfgr Received: 2019-11-06
• Device Manufacturer Date: 2018-11-02
• Date Added to Maude: 2019-11-29
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: PAULA BIXBY
• Manufacturer Street: 8200 CORAL SEA ST NE
• Manufacturer City: MOUNDS VIEW MN 55112
• Manufacturer Country: US
• Manufacturer Postal: 55112
• Manufacturer Phone: 7635055378
• Manufacturer G1: HEARTWARE, INC.
• Manufacturer Street: 14400 NW 60TH AVE
• Manufacturer City: MIAMI LAKES FL 33014
• Manufacturer Country: US
• Manufacturer Postal Code: 33014
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Generic Name: VENTRICULAR (ASSIST) BYPASS
• Product Code: DSQ
• Date Received: 2019-11-29
• Model Number: 1104JP
• Catalog Number: 1104JP
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HEARTWARE, INC.
• Manufacturer Address: 14400 NW 60TH AVE MIAMI LAKES FL 33014 US 33014

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-11-29