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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01U
Device Problem Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
At 1544, the pump began alarming, and the machine placed in standby. Alarms stated balloon leak was detected. Upon nursing assessment of balloon there were condensation and blood specks noted in balloon catheter. Cardiology notified and patient was taken to cath lab emergently to replace the balloon. When balloon was removed it was noted that the balloon had ruptured.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
45 barbour pond drive
wayne NJ 07470
MDR Report Key13885002
MDR Text Key287797601
Report Number13885002
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number0684-00-0576-01U
Device Catalogue Number0684-00-0576-01U
Device Lot Number30001674470027
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2022
Date Report to Manufacturer03/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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