MAUDE Adverse Event Report: MAQUET INTRA AORTIC BALLOON PUMP

Model Number CS100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/26/2017

Event Type  Injury  

Event Description

Cs100 iabp ceid#(b)(4) failed during a stemi.

• Brand Name: INTRA AORTIC BALLOON PUMP
• Type of Device: INTRA AORTIC BALLOON PUMP
• Manufacturer (Section D): MAQUET
• MDR Report Key: 6854759
• MDR Text Key: 85811202
• Report Number: MW5072071
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: CS100
• 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): Life Threatening
• Patient Age: 68 YR