BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 23299441 · Received October 15, 2025

    Report

    Report Number
    2249723-2025-0004303
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 24, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D8, D9, E1, E2 G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD: D10, H6 (MEDICAL DEVICE PROBLEM CODE). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT AND THE PROBLEM WAS UNABLE TO BE REPRODUCED REPORTED. THE FSE REPLACED THE PCBA, VIDEO GENERATOR (0670-000-1182) AS PRECAUTION AND THE DEVICE RETURNED TO EXPECTED USE. THE FSE CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS NOISE APPEARS ON THE TOUCH PANEL SCREE ISSUE. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS NOISE APPEARS ON THE TOUCH PANEL SCREE ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993026 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown