BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23921259 · Received December 30, 2025

    Report

    Report Number
    2249723-2025-0005438
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 9, 2025
    Report Date
    March 31, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: E1 (INITIAL REPORTER) AND E3. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THEY CONFIRMED THE UNIT HAD A HELIUM LEAK. THE TESTS FAILED AND THE HELIUM RESERVOIR 0997-00-0565 WAS REPLACED TO RESOLVE THE ISSUE. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. FAT WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 WITH A REPORTED UNIT FAILURE OF THE UNIT LEAKING HELIUM. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A BROKEN FITTING IN THE CVI PORT. SEE ATTACHMENT. UNABLE TO INSTALL AND TEST. POSSIBLE CAUSE IS A SERVICE ISSUE WHEN THE PART WAS REMOVED FROM THE DEVICE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AV.

    Additional Manufacturer Narrative · 0

    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 THAT PRIOR TO USE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000526 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 NA Unknown