BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24219658 · Received January 30, 2026

    Report

    Report Number
    2249723-2026-0000995
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 9, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. IN THIS COMPLAINT, BALLOON PUMP LATCH ON THE LOWER BIN IS BROKEN, THAT IS A COSMETIC DAMAGE, MAKING IT NON REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL 2249723-2026-0000995 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED BY THE CUSTOMER THAT THE LATCH ON THE LOWER BIN CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) WAS BROKEN. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596925 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 UNKNOWN.