BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 24207736 · Received January 29, 2026

    Report

    Report Number
    2249723-2026-0000963
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 11, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107790
    PMA / PMN Number
    K031636
    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, E3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED HYDR CMPNT PUMP ASSY DC KNF (D102-00-0001). AFTER REPLACEMENT, ALL FUNCTIONAL PARAMETERS OF THE EQUIPMENT WERE TESTED AND FOUND TO BE NORMAL BEFORE DELIVERY TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1: EVENT SITE NAME: (B)(6). EVENT SITE TELEPHONE: (B)(6). EVENT SITE ADDRESS: NO. (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, DURING ROUTINE CHECK, CS100 SYSTEM EXPERIENCED AN ELECTRICAL TEST FAILURE ALARM WITH CODE 50. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567173 CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-45 10607567107790

    Patients

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