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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2022
Event Type  malfunction  
Event Description
Pt was placed on intra-aortic balloon pump (iabp) during urgent procedure.All protocols followed for balloon pump insertion.When starting up console, an error came across the screen that roughly read "blood detected in line".Helium line inspected with no blood present.Iabp was placed on standby.Console was exchanged out for new iabp console.Iabp was restarted.New error appeared that roughly read "iab system failure".Balloon pump did not appear to inflate in body (verified with x-ray).New balloon pump system obtained and inserted into patient, with second console attached.Pt left room with balloon pump working properly on 1:1 inflation.Examination revealed the problem was with the balloon catheter not the pump.Fault balloon catheter was retrieved and sent to company for inspection.
 
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Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
45 barbour pond drive
wayne NJ 07470
MDR Report Key16203782
MDR Text Key307701078
Report Number16203782
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 Nurse
Type of Report Initial
Report Date 12/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2022
Event Location Hospital
Date Report to Manufacturer01/19/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14600 DA
Patient SexMale
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