MAUDE Adverse Event Report: MAQUET MAQUET IAB-SENSATION PLUS 8 FRENCH 50 CC BALLOON; IAB - SENSATION PLUS 8 FRENCH 50 CC BALLOON

Model Number 30000214150443

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  Injury  

Event Description

Gas loss in iab circuit occurred every two hours throughout the day and night shifts requiring a manual iab fill to resume pumping.Diagonal would fail to keep the iab inflated requiring manual fills every 2 hours, all connections tight, and no blood in tubing, pt.All trouble shooting techniques employed as required.

• Brand Name: MAQUET IAB-SENSATION PLUS 8 FRENCH 50 CC BALLOON
• Type of Device: IAB - SENSATION PLUS 8 FRENCH 50 CC BALLOON
• Manufacturer (Section D): MAQUET
• MDR Report Key: 5811778
• MDR Text Key: 50191612
• Report Number: MW5063565
• 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: No Information
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Device Operator: Health Professional
• Device Model Number: 30000214150443
• Device Lot Number: 068400057601U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR