IMPELLA RP IMPELLA RP US PUMP SET 004334

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-01 for IMPELLA RP IMPELLA RP US PUMP SET 004334 manufactured by Abiomed, Inc..

MAUDE Entry Details

• Report Number: 1220648-2019-00128
• MDR Report Key: 8748901
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-07-01
• Date of Report: 2019-09-03
• Date of Event: 2019-06-07
• Date Facility Aware: 2019-06-07
• Date Mfgr Received: 2019-08-12
• Device Manufacturer Date: 2019-01-17
• Date Added to Maude: 2019-07-01
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. RALPH BARISANO
• Manufacturer Street: 22 CHERRY HILL DR.
• Manufacturer City: DANVERS MA 01923
• Manufacturer Country: US
• Manufacturer Postal: 01923
• Manufacturer G1: ABIOMED, INC.
• Manufacturer Street: 22 CHERRY HILL DR.
• Manufacturer City: DANVERS MA 01923
• Manufacturer Country: US
• Manufacturer Postal Code: 01923
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMPELLA RP
• Generic Name: TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
• Product Code: PYX
• Date Received: 2019-07-01
• Returned To Mfg: 2019-06-18
• Model Number: IMPELLA RP US PUMP SET
• Catalog Number: 004334
• Lot Number: 1386766
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABIOMED, INC.
• Manufacturer Address: 22 CHERRY HILL DR. DANVERS MA 01923 US 01923

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-01