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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-58
Medical Device Problem Code Gas Output Problem (1266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/25/2025
Type of Reportable Event Malfunction
Event or Problem Description
It was reported by customer during use that cardiosave intra-aortic balloon pump (iabp) counterpulsation balloon console gives a low vacuum error.No patient harm or injury reported.
 
Additional Manufacturer Narrative
Due to character limitation in e1: (b)(6).A supplemental report will be submitted upon completion of our investigation.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V
Common Device Name
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP.
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
henry pena
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key21581610
Report Number2249723-2025-0001169
Device Sequence Number8868420
Product Code DSP
UDI-Device Identifier10607567108339
UDI-Public(01)10607567108339
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K063525
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,User Facility,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/12/2025
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
Operator of Device Health Professional
Device Model Number0998-00-3023-58
Device Catalogue Number0998-00-3023-58
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/25/2025
Initial Report FDA Received Date03/12/2025
Is the Device Labeled for Single Use? (Y/N) No
Usage of Device Reuse
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNKNOWN.
Patient SexUnknown
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