BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22042554 · Received May 19, 2025

    Report

    Report Number
    2249723-2025-0002255
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 23, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITS - EVENT SITE NAME (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H11. AFTER FURTHER REVIEW, AN INITIAL EMDR FOR THIS COMPLAINT WAS INCORRECTLY SUBMITTED. THE RECORD IS BEING CANCELLED AS IT WAS CREATED IN ERROR AS IT IS DUPLICATE COMPLAINT. THE INCIDENT WAS DETERMINED TO BE A DUPLICATE REPORT TO COMPLAINT (AUTHORITY MFG REPORT NUMBER (2249723-2025-0002256). AS A RESULT, NO FOLLOW UP EMDR WILL BE SENT. PLEASE CANCEL THIS RECORD IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING USE OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP, A FAN FAILURE WAS DETECTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136197 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.