MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; TEMPORARY CARDIAC SUPPORT BLOOD PUMP

Catalog Number 0048-0003

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

Device stopped due to fail safe perimeters.

• Brand Name: IMPELLA
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• MDR Report Key: 7057417
• MDR Text Key: 92875356
• Report Number: 7057417
• Device Sequence Number: 1
• Product Code: PBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0048-0003
• Other Device ID Number: 453054401-00480003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR