MAUDE Adverse Event Report: MAQUET GETINGE GROUP / DATASCOPE CORP. MEGA 8FR INTRA-AORTIC BALLOON AND INSERTION KIT STATLOCK IAB DEVICE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 3000114817

Device Problem Inability to Auto-Fill (1044)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  malfunction  

Event Description

Autofill error.Fda safety report id #: (b)(4).

• Brand Name: MEGA 8FR INTRA-AORTIC BALLOON AND INSERTION KIT STATLOCK IAB DEVICE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET GETINGE GROUP / DATASCOPE CORP.
• MDR Report Key: 11633675
• MDR Text Key: 244668371
• Report Number: MW5100635
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2022
• Device Lot Number: 3000114817
• 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 Age: 70 YR
• Patient Weight: 80