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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2020
Event Type  malfunction  
Event Description
Cardiac intensive care unit (cicu) fellow; doctor called to bedside to assess intra-aortic balloon pump (iabp) low augmentation pressure alarm.Waveform on balloon pump is normal.Iabp reading of 42/5.Cicu attending, doctor, determined that it is a balloon malfunction.Cuff reading blood pressure within defined limits, titrating meds per cuff reading.Doctor requested another arterial line placement.Cicu resident at bedside to place left radial art line.Art line pressures correlating with cuff pressure.Iabp removed per cicu fellow.No issues upon removal, balloon intact.Patient tolerated well, vital signs stable.
 
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Brand Name
CARDIOSAVE RESCUE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
45 barbour pond drive
wayne NJ 07470
MDR Report Key10939981
MDR Text Key219332697
Report Number10939981
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 12/01/2020
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2020
Event Location Hospital
Date Report to Manufacturer12/03/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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