BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 24244082 · Received February 3, 2026

    Report

    Report Number
    2249723-2026-0001056
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 11, 2026
    Report Date
    February 11, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THIS IS A NON-REPORTABLE EVENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL 2249723-2026-0001056 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, THE FULL EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    USER CALLED INTO EMERGENCY SUPPORT PROGRAM (ESP) LINE DURING CARDIOSAVE INTRA AORTIC BALLOON PUMP THERAPY HAD AUGMENTATION MALFUNCTION. THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541945 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