BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 24206873 · Received January 29, 2026

    Report

    Report Number
    2249723-2026-0000928
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 5, 2026
    Report Date
    March 7, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567109008
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDIONAL REPORTER NAME IS (B)(6). ADDIONAL EVENT SITE EMAIL IS (B)(6). UPDATED FIELDS: B4, G3, G6, H2, H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11, E1 (INITIAL REPORTER, EVENT SITE EMAIL). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO REPRODUCE THE REPORTED MALFUNCTION. THE FSE RESET THE CONNECTION OF THE VIDEO RECEIVER BOARD, FLAT CABLE, AND BACKPLANE BOARD, BUT THE ISSUE PERSISTED. THE FSE REPLACED THE UPPER DISPLAY MONITOR TO LCD CABLE ASSEMBLY (0012-00-1558). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY CHECKS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ROUTINE CHECK THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP'S DISPLAY WAS FLICKERING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272151 CARDIOSAVE HYBRID TYPE D PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-33 10607567109008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.