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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 Problems Material Rupture (1546); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2022
Event Type  malfunction  
Event Description
Getinge intra-aortic balloon pump (iabp) balloon was found to be ruptured upon placing the balloon into the sheath.It appeared to be defective prior to placement.No replacement available at this time, this was our last balloon.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key16060418
MDR Text Key306256236
Report Number16060418
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109633
UDI-Public(01)10607567109633
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2022
Event Location Hospital
Date Report to Manufacturer12/28/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/28/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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