BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 24032613 · Received January 12, 2026

    Report

    Report Number
    2249723-2026-0000347
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 5, 2025
    Report Date
    March 23, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ANOTHER CONTACT INFO: (B)(6). UPDATED FIELDS: B4,D9,E3,G3,G6,H2,H3,H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) WAS NOT ABLE TO CONFIRM THE FAILURE. THE FSE REPLACED THE FIBER OPTIC MODULE. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AS PER MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THAT CARDIOSAVE HYBRID TYPE B PLUG HAD AN ERROR WHERE IT WAS UNABLE TO SENSE THE FIBER OPTIC CABLE. CUSTOMER REPORTED FIBER OPTIC FAILURE MESSAGE. THERE WERE NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407340 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