BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22249514 · Received June 17, 2025

    Report

    Report Number
    2249723-2025-0002619
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 3, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE PARENT COMPLAINT (TW: (B)(4)) IS BEING CANCELLED AS IT WAS CREATED IN ERROR AS IT IS DUPLICATE TO COMPLAINT # TW (B)(4). THE INCIDENT WAS DETERMINED TO BE A DUPLICATE REPORT TO COMPLAINT (B)(4) (AUTHORITY MFG REPORT NUMBER (2249723-2025-0002584). AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE. REVERT ALL SECTIONS TO BLANK: B. ADVERSE EVENT OR PRODUCT PROBLEM D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER G. ALL MANUFACTURERS H. DEVICE MANUFACTURERS ONLY.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS CABLE ECG PORT DOES NOT WORK, MULTIPLE CABLES WAS TRIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547469 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.