BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE D PLUG

    MDR report key: 23601766 · Received November 20, 2025

    Report

    Report Number
    2249723-2025-0004762
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 22, 2025
    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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTION IN BLOCK E1. E1 EVENT SITE NAME IS (B)(6). UPDATED FIELDS: B4, G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE, HEALTH EFFECT ¿ IMPACT CODES), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE LOWER LCD INPUT CABLE WAS DISCONNECTED AND RECONNECTED. IT RESOLVED THE ISSUE, AND THE UNIT WAS WORKING PROPERLY. TO PREVENT THE SAME PROBLEM FROM RECURRING, THE LOWER LCD INPUT CABLE WAS REPLACED (0012-00-1558). THE DISPLAY WORKING PROPERLY, AND ALL FUNCTIONAL TEST PASSED. THE UNIT HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION. CORRECTED FIELD : E1 ( EVENT SITE EMAIL ) , D1.

    Description of Event or Problem · 0

    IT WAS REPORTED BY COSTUMER THAT DURING ROUTINE CHECK THE DISPLAY OF CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS BLINKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314826 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