BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 22282760 · Received June 18, 2025

    Report

    Report Number
    2249723-2025-0002646
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 4, 2025
    Report Date
    November 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0002646 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDING, CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) STATED CUSTOMER REPORTED PUMP DISPLAYS ¿LEAK IN IABP CIRCUIT¿. COULD NOT DUPLICATE ISSUE. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. DEVICE WAS GIVEN TO CUSTOMER AND CLEARED FOR CUSTOMER USE. THIS ERROR GENERALLY REFERS TO A LEAK IN THE BALLOON CATHETER OR CIRCUIT.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H11. UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL THIS RECORD # 2249723-2025-0002646 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) IS ALARMING FOR A LEAK. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864210 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown