BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 23595761 · Received November 19, 2025

    Report

    Report Number
    2249723-2025-0004757
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 24, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN E1 EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G3, G6, H2, H3, H6(MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT, AND THE PROBLEM WAS FOUND TO BE DUE TO A FAULT IN THE FRONTEND BOARD PCB CABLE. ECG INPUT TO FRONT-END PCB CABLE (0012-00-0976) AND ECG PATIENT TRUNK CABLE - 5 LEAD (0012-00-1155-02) HAVE BEEN REPLACED. TESTING HAS BEEN COMPLETED SUCCESSFULLY. UNIT HAS BEEN HANDED OVER TO THE USERS IN GOOD WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK BY CUSTOMER THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD ECG PORT ISUUE. NO ONE WAS HARMED ON SITE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442476 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown