BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 23232655 · Received October 7, 2025

    Report

    Report Number
    2249723-2025-0004157
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 27, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD- H8. DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE ADDRESS-2 (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE CARDIOSAVE #B MACHINE, EQUIPMENT NUMBER 6515-070-0001/17/66, FOUND THAT THE LOGFILE HAD FAULT CODE #37 RELATED TO THE WARNING AUTOFILL FAIL - IAB DISCONNECT. CHECKED THE MACHINE USING THE ALL MANIFOLD TEST: ALL PASS, METHOD - CALIBRATE DRIVE REGULATOR: VALUE WAS IN THE RANGE, CAN BE USED NORMALLY. RUN THE TEST THROUGH THE TRAINER. THE MACHINE CAN RUN THE TEST. NO AUTOFILL FAIL SYMPTOMS WERE FOUND.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME : (B)(6). EVENT SITE CITY : (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 CUSTOMER THAT BEFORE USE,THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AUTOFILL FAILURE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747353 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown