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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problem Component Falling (1105)
Patient Problems Bradycardia (1751); Death (1802)
Event Date 03/28/2016
Event Type  Death  
Event Description
Patient with an intra-aortic balloon pump (iabp) was in the process of being transported by helicopter from transferring hospital to accepting hospital.Upon arrival at accepting hospital, helicopter had landed on designated helipad after which patient was prepared for removal from aircraft.The iabp was lifted out by one crew member, after which the iabp battery reportedly fell out of the console, the balloon pump reportedly shut off and the patient subsequently became bradycardic.Two crew members proceeded to lift out the litter with patient.The battery was returned to its original position and the pump reportedly turned back on immediately and began to operate appropriately.However while patient was being transported into the hospital, patient became pulseless and cpr was started.Patient was taken directly to the emergency room.Despite all resuscitation efforts, patient died.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield, FL 07004
MDR Report Key5669316
MDR Text Key45599782
Report Number5669316
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number0998-00-3023-53
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/13/2016
Device Age13 YR
Event Location Other
Date Report to Manufacturer05/13/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age50 YR
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