BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL

    MDR report key: 23717692 · Received December 4, 2025

    Report

    Report Number
    2249723-2025-0004943
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 12, 2025
    Report Date
    January 3, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107875
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, E1 (EMAIL), H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) OBSERVED THERE WAS NO DISPLAY ON THE MACHINE. FSE CHECKED AND FOUND PCB INVERTER PART NO. D-671-00-0230 DEFECTIVE NEED REPLACEMENT. ON 17/12/2025 FSE REPLACED PCB INVERTER PART NO. (D-671-00-0230), CUSTOMER PURCHASED), CHECKED AND FOUND UNIT WORKING OK, AND READY FOR USE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN THE E1 SECTION THE FULL EVENT SITE ADDRESS IS: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT DURING ROUTINE CHECK THE CS100 INTRA AORTIC BALLOON PUMP HAD DISPLAY FAILURE. THERE WAS NO PATIENT INVOLVEMENT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880354 CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-UC-3013-55 10607567107875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.