BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 24160606 · Received January 23, 2026

    Report

    Report Number
    2249723-2026-0000815
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 2, 2026
    Report Date
    February 18, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT: E1(EVENT SITE NAME)- (B)(6). (TELEPHONE)- (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2026-0000888. PLEASE REFER TO MFG REPORT NUMBER 2249723-2026-0000888 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2026-0000815 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING MAINTENANCE THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP IABP HAD A DEFECTIVE DISPLAY. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220135 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown