BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 24173284 · Received January 24, 2026

    Report

    Report Number
    2249723-2026-0000840
    Event Type
    Malfunction
    Date Received
    January 24, 2026
    Date of Event
    January 4, 2025
    Report Date
    March 11, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108575
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS) GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED THE HYDR CMPNT PUMP ASSY DC KNF (0102-00-0001). ALL FUNCTIONAL PARAMETERS OF THE EQUIPMENT WERE NORMAL, AND THE EQUIPMENT WAS DELIVERED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1: EVENT SITE NAME - (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED AN ALARM INDICATING AN ELECTRICAL TEST FAILURE 50 UPON STARTUP. THE ISSUE OCCURRED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234386 CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-45 10607567108575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown