BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 23765578 · Received December 10, 2025

    Report

    Report Number
    2249723-2025-0005013
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 18, 2025
    Report Date
    April 2, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D8, D9, G3, G6, H2, H3 , H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES , INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D10. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED THE UPPER DISPLAY BEZEL (D380-00-0559), UPPER HINGE COVER (D380-00-0561), UPPER INSIDE BADGE LABEL (D334-00-1809) AND PROD ID LABEL (D334-00-1810-01) DUE TO DAMAGE. ALL WORK WAS PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS AND PROCEDURES OUTLINED IN THE SERVICE MANUAL.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. (B)(6). TO CHARACTER LIMITATION IN E1 FOR EVENT SITE CITY: 5-7-1 KOJIDAI, NISHI-KU, KOBE CITY

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THE DISPLAY FELL WHEN THE MAIN UNIT WAS DOCKED WITH THE CART. ACCORDING TO THE CUSTOMER, THE ISSUE OCCURRED WHILE ATTEMPTING TO RETURN THE SYSTEM TO HYBRID MODE AFTER OPERATING IN RESCUE MODE. NO PATIENT WAS INVOLVED, AND NO HARM WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN THE DISPLAY FELL OFF WHEN THE MAIN UNIT AND CART WERE DOCKED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69176 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