BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22746796 · Received August 8, 2025

    Report

    Report Number
    2249723-2025-0003384
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 27, 2025
    Report Date
    September 12, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT WAS DUPLICATE OF MDR REPORT 2249723-2025-0003426. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING USE CALLED REQUESTING ASSISTANCE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD REGARDING A SPONTANEOUS SHUTDOWN WHILE ENTERING THE TRANSPORTATION VEHICLE. CUSTOMER STATED THAT WHEN HAD TILTED THE CONSOLE, AND A LOUD NOISE ALARMED, AND THE PUMP TURNED OFF. THERE WAS NO ALARMS PRIOR TO SHUT DOWN. THE PUMP HAD BEEN OFF FOR APPROXIMATELY 3 MINUTES. HE STATED THEY WERE CURRENTLY TRANSPORTING BACK TO THE ICU TO SWITCH OUT CONSOLES. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243521 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 63 YR Male UNKNOWN.