BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22910239 · Received August 28, 2025

    Report

    Report Number
    2249723-2025-0003614
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 9, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    AS PER RECENT INFORMATION, AFTER FURTHER REVIEW, THIS COMPLAINT WILL BE NON-REPORTABLE 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 MFG REPORT NUMBER - 2249723-2025-0003614 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS ALARMING GAS LOSS IN AIV CIRCUIT. NO PATIENT INVOLVEMENT REPORTED AND NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519760 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown