BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 24065535 · Received January 14, 2026

    Report

    Report Number
    2249723-2026-0000450
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 24, 2025
    Report Date
    March 12, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELDS: B5, B6, B7 ,D10, H6 (HEALTH EFFECT IMPACT CODE) CS100 UPGRADED TO CS300 CS300 INTRA AORTIC BALLOON PUMP, ENGLISH, 110V CATALOG #: 0998 00 3023 53 UDI #: (B)(4). 510K: K063525 A GETINGE FIELD SERVICE ENGINEER WAS DISPATCHED TO EVALUATE THE UNIT. THE REPORTED THAT THE SYSTEM WAS MISSING A HELIUM TANK AND A WASHER. HOWEVER THIS WAS A NON ISSUE BECAUSE THE BIOMED SUPPLIED THE SPARE TANK AND WASHER. THE FSE INSTALLED THE NEW HELIUM TANK OBSERVED NO AUDIBLE SOUNDS OF HELIUM LEAK UPON NEW TANK INSTALLATION. SYSTEM PRESSURIZED AND HELIUM TANK CLOSED TO TEST FOR LEAKAGE. SYSTEM LOST NO HELIUM OVER HALF HOUR TEST. UNIT SHOWS NO UNEXPECTED LOSS OF HELIUM DURING PUMPING. UNIT PASSES ALL INTERNAL LEAKAGE TESTS. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: B5, H6 (TYPE OF INVESTIGATION).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK ISSUE. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK ISSUE. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS100 INTRA AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK ISSUE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125904 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-53 10607567107394

    Patients

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