BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 22492403 · Received July 14, 2025

    Report

    Report Number
    2249723-2025-0002998
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 5, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS : H6 ( COMPONENT CODES ). UPDATED FIELDS: B4, G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11. THE FSE REPLACED THE HIGH PRESSURE REDUCER (0103-00-0637), O-RING (0354-00-0208) AND RAN TEST. FUNCTION TESTS PERFORMED WITH POSITIVE OUTCOME. THE EQUIPMENT WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. THERE WAS NO PATIENT INVOLVED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 (EVENT SITE TELEPHONE), G3, G6, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TESTING , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD SMALL HELIUM LEAK. THERE WAS NO PATIENT INVOLVED

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728589 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown