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U.S. Department of Health and Human Services

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

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MAQUET MAQUET IAB-SENSATION PLUS 8 FRENCH 50 CC BALLOON IAB - SENSATION PLUS 8 FRENCH 50 CC BALLOON Back to Search Results
Model Number 30000214150443
Device Problem Gas 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.
 
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Brand NameMAQUET IAB-SENSATION PLUS 8 FRENCH 50 CC BALLOON
Type of DeviceIAB - SENSATION PLUS 8 FRENCH 50 CC BALLOON
Manufacturer (Section D)
MAQUET
MDR Report Key5811778
MDR Text Key50191612
Report NumberMW5063565
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received07/19/2016
Device Operator
Device Model Number30000214150443
Device Lot Number068400057601U
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/19/2016 Patient Sequence Number: 1
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