BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 23289752 · Received October 15, 2025

    Report

    Report Number
    2249723-2025-0004291
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    January 27, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 (EVENT SITE ADDRESS), G3, G6, H2, H11. CORRECTED FIELDS: D10, E1 (INITIAL REPORTER, EVENT SITE EMAIL), H6 (INVESTIGATION FINDINGS). DUE TO CHARACTER LIMITATION IN BLOCK E1: INITIAL REPORTER: (B)(6). EVENT SITE ADDRESS: (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, B5, D5, D9, E1, E2, E3, G2, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. GETINGE FIELD SERVICE TECHNICIAN (FST) DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED. THE FST TESTED AND REPLACED HYDR CMPNT PUMP ASSY DC KNF (0102-00-0001). AFTER THE REPLACEMENT, THE AVERAGE PRESSURE MET THE SPECIFICATIONS. TESTED THE OPERATION OF OTHER COMPONENTS. FOUND TO BE FUNCTIONING NORMALLY. ON 24-NOV-2025 THE FST CHANGED ADDITIONAL PUMP MAINTENANCE SPARE PARTS AND TESTED OVERALL OPERATION. THE MACHINE CAN WORK NORMALLY.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS, 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 DURING PREVENTATIVE MAINTENANCE THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD PRESSURE RELATED MALFUNCTION.THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD PRESSURE RELATED MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2647184 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-55 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown