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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE/ DATASCOPE CORP SENSATION PLUS 7.5 FR. & 8FR. IAB CATHETERS SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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GETINGE/ DATASCOPE CORP SENSATION PLUS 7.5 FR. & 8FR. IAB CATHETERS SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number S/N 0684-00-0568-01U
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 03/06/2022
Event Type  Injury  
Event Description
The patient had an indwelling intra-aortic balloon pump. Iabp alarm with leak in circuit, on inspection noted to have blood backfilling balloon tubing indicating balloon rupture. Balloon placed on stand by and or team called in for emergent exchange. Fda safety report id # (b)(4).
 
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Brand NameSENSATION PLUS 7.5 FR. & 8FR. IAB CATHETERS
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
GETINGE/ DATASCOPE CORP
wayne NJ 07470
MDR Report Key13720468
MDR Text Key287030038
Report NumberMW5107998
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS/N 0684-00-0568-01U
Device Lot Number3000172714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/09/2022 Patient Sequence Number: 1
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