BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 23787169 · Received December 12, 2025

    Report

    Report Number
    2249723-2025-0005053
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 29, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1: INITIAL REPORTER: (B)(6). UPDATED FIELDS - B5, D9, B4, G3, G6, H3, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D5, E2, E3, E4, E1, G2. IT WAS REPORTED THAT DURING FSCA PROCESS THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) SHUTS DOWN WHEN UNPLUGGED. THE DEVICE WAS INSPECTED FOR FSCA PROCEDURES NUMBERED 2249723-05/05/2023-008-C AND 2249723-06/02/2023-013-C / (B)(4). HOWEVER, THE MALFUNCTIONS WERE NOT RELATED TO FSCA.THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. IT WAS DETERMINED THAT THE DEVICE SHUTS DOWN WHEN UNPLUGGED DURING THE FSCA PROCEDURE. SERVICE SCHEDULING IS REQUIRED FOR FAULT DIAGNOSIS. THE DEVICE IS NOT SUITABLE FOR CLINICAL USE. THE SERVICE ORDER WAS CLOSED DUE TO TIMEOUT BECAUSE THE INFRASTRUCTURE REQUIREMENTS NOTIFIED BY GETINGE TECHNICAL SERVICE WERE NOT MET BY THE ORGANIZATION. THE CUSTOMER DOES NOT HAVE AN AGREEMENT WITH GETINGE. A PAID SERVICE PRICE QUOTE WAS SENT FOR FAULT DIAGNOSIS, BUT THE CUSTOMER DID NOT APPROVE IT. IN FUTURE IF WE RECEIVE ANY UPDATE WILL REOPEN AND UPDATE THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: H6 (INVESTIGATION FINDINGS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED A DEVICE SHUTDOWN WHEN UNPLUGGED. THERE WAS NO PATIENT INVOLVEMENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED A DEVICE SHUTDOWN WHEN UNPLUGGED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2712277 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