BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 24762798 · Received April 2, 2026

    Report

    Report Number
    2249723-2026-0001971
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 14, 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

    UPDATED FIELDS: B4, G3, G6, H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) CHECKED AND CONFIRMED THE MENTIONED ISSUE. THE FSE RESET THE CONNECTIONS OF THE UPPER DISPLAY CABLE TO LCD MONITOR, VIDEO GENERATOR BOARD AND RESET THE COILED CABLE. THE PROBLEM STILL PERSISTED. THE FSE STATED THAT THE UPPER DISPLAY MONITOR TO LCD CABLE ASSEMBLY WAS DEFECTIVE. THE FSE REPLACED THE UPPER DISPLAY MONITOR TO LCD CABLE ASSEMBLY (0012-00-1558) AND THE DEVICE PASSED ALL SAFETY AND FUNCTIONAL CHECKS. THE DEVICE 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 BY THE CUSTOMER THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS FLICKERING WHEN SWITCHING ON. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830248 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.