BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 23886826 · Received December 24, 2025

    Report

    Report Number
    2249723-2025-0005233
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 2, 2025
    Report Date
    March 6, 2026
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE OPERATION OF THE MONITOR DURING THE SAFETY DISK REPLACEMENT WORK, AN ABNORMALITY OCCURRED IN THE SCREEN DISPLAY, CAUSING IT TO BECOME DISTORTED. AFTER CHECKING THE INSIDE OF THE DEVICE, IT WAS FOUND THAT THE CAUSE WAS A POOR CONNECTION BETWEEN THE UPPER DISPLAY BOARD CONNECTED TO THE TOUCH PANEL AND THE MONITOR CABLE. RECONNECTING THE BOARD DID NOT RESULT IN A REPRODUCIBLE PROBLEM, BUT AS A PRECAUTION, THE UPPER DISPLAY BOARD (D670-00-1183) AND MONITOR CABLE (D012-00-1558) WERE REPLACED. THE PROBLEM WAS NOT REPRODUCIBLE DURING AN OPERATIONAL INSPECTION AFTER REPLACEMENT, AND THE RESULTS WERE GOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN GETINGE FSE CHECKED THE OPERATION OF THE MONITOR OF CARDIOSAVE HYBRID, 3.1 EDITION INTRA-AORTIC BALLOON PUMP (IABP) DURING THE SAFETY DISK REPLACEMENT WORK, AN ABNORMALITY OCCURRED IN THE SCREEN DISPLAY, CAUSING IT TO BECOME DISTORTED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830460 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