BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 23584435 · Received November 18, 2025

    Report

    Report Number
    2249723-2025-0004739
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 23, 2025
    Report Date
    March 18, 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: A4, B4, D9 (RETURN TO MANUFACTURE DATE), G3, G6, H2, H6 (TYPE OF INVESTIGATION, COMPONENT CODES AND INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: B5. FIELDS D1 AND D4 OF THE EMDR IS FOR ORIGINAL IABP CS100, HOWEVER THIS IABP WAS UPGRADED TO A CS300 INTRA AORTIC BALLOON PUMP, PMA 510K IS K063525 FOR CS300. A GETINGE FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND IDENTIFIED ERROR CODES ASSOCIATED WITH THE MAIN BOARD. THE FSE REPLACED THE MAIN BOARD PCB AND PERFORMED A PREVENTIVE MAINTENANCE (PM) INSPECTION, COMPLETING ALL CHECKLIST PROCEDURES IN ACCORDANCE WITH THE MANUFACTURER¿S SPECIFICATIONS.THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT DURING USE ON PATIENT, THE CS100 UPGRADED TO CS300 INTRA-AORTIC BALLOON PUMP (IABP), HAD AUTO FILL FAILURE ALARM. IABP TROUBLE SHOOTING AND HELIUM TANK CHANGED, FAILURE ALARM CONTINUED, IABP MACHINE CHANGED, NO ALARM. NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT DURING USE ON PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP), HAD AUTO FILL FAILURE ALARM. IABP TROUBLE SHOOTING AND HELIUM TANK CHANGED, FAILURE ALARM CONTINUED, IABP MACHINE CHANGED, NO ALARM. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783673 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 62 YR Female