BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 24032588 · Received January 12, 2026

    Report

    Report Number
    2249723-2026-0000343
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 19, 2025
    Report Date
    March 10, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE FAILURE MODE INVOLVED IN THE EVENT DID NOT LEAD TO AND DOES NOT HAVE POTENTIAL TO LEAD TO THE OUTCOMES OF A SERIOUS INCIDENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2026-0000343 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) A LOOP LEAK ALARM DURING USE. THERE WAS NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92914 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.