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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-53
Device Problems Leak/Splash (1354); Battery Problem (2885); Failure of Device to Self-Test (2937)
Patient Problem Insufficient Information (4580)
Event Date 08/13/2021
Event Type  malfunction  
Event Description
We are seeing the battery life becoming shorter and shorter with our fleet of iabp's.We used to see at least 3 years of life.Below are work order notes from one of our iabp's.8 years ago- replaced batteries, old batteries leaked.5 years ago- performed battery test.Test failed at 73 minutes.Needs 120 to pass.Charged over weekend to confirm.5 years ago- performed second battery test.Test failed at 60 minutes.5 years ago- submit pr for replacement batteries.5 years ago- found we have two patients on iabp and this device is needed.Completed balance of pm and rts.3 years ago- located device and brought to shop for pm.Performed battery test and battery test failed, running less than 90 minutes.Will need to replace batteries and complete pm next week.3 years ago- replaced batteries and ran battery test.Completed pm.2 years ago- swapped out batteries.Performed battery pm.Batteries passed last year- failed battery test.Upon last completion of repair.Ran battery check.Failed battery check.Ordering new batteries.Last year- replaced batteries, charging over night then going to perform battery test tomorrow.Last year- started battery test.Passed battery test.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
45 barbour pond dr
wayne NJ 07470
MDR Report Key13470751
MDR Text Key285167567
Report Number13470751
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 Other Health Care Professional
Type of Report Initial
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2021
Device Age9 YR
Date Report to Manufacturer02/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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