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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2019
Event Type  malfunction  
Event Description
Patient had an 8 french 50 ml balloon intra aortic balloon pump (iabp) placed at femoral insertion site for worsening tachypnea.4 days later, the iabp was removed due to a malfunctioning balloon.Upon removal, blood was noted in the helium gas line.
 
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Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key9659332
MDR Text Key177378538
Report Number9659332
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 Risk Manager
Type of Report Initial
Report Date 10/24/2019,10/23/2019
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 Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2019
Event Location Hospital
Date Report to Manufacturer02/03/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age26280 DA
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