BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 23919979 · Received December 30, 2025

    Report

    Report Number
    2249723-2025-0005395
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 13, 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

    EVENT SITE TELEPHONE: (B)(4). DUE TO CHARACTERIZATION LIMIT E1: EVENT SITE NAME: (B)(6) HOSPITAL. EVENT SITE ADDRESS: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED HYDR CMPNT PUMP ASSY DC KNF (D102-00-0001). AFTER REPLACING THE PART, ALL FUNCTIONS AND PARAMETERS OF THE TESTING EQUIPMENT WERE NORMAL, AND IT WAS DELIVERED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BEFORE USE THE CS100 INTRA-AORTIC BALLOON PUMP(IABP) ALARMED WITH ELECTRICAL TEST FAILURE CODE 50 UPON STARTUP. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272754 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.