MAUDE Adverse Event Report: ABIOMED INC. IMPELLA CONTROLLER; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 0042-0000-US

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 09/02/2018

Event Type  Injury  

Event Description

The patient was moving from the surgical table to the bed and all of a sudden, the impella console lost its signal and afterwards the impella software shutdown.

• Brand Name: IMPELLA CONTROLLER
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABIOMED INC. ; danvers MA 01923
• MDR Report Key: 7910023
• MDR Text Key: 121991534
• Report Number: MW5080098
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 0042-0000-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 78