BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22381755 · Received July 2, 2025

    Report

    Report Number
    2249723-2025-0002827
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 18, 2025
    Report Date
    October 16, 2025
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED THE LEAK AND REPLACED THE HELIUM REGULATOR (0103-00-0637) AND BUSHING (0358-00-0069) TO FIX THE ISSUE. ALL FUNCTIONAL AND SAFETY CHECKS HAVE BEEN PERFORMED TO MEET FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H3, H11. CORRECTED FIELD - H6 (INVESTIGATION CONCLUSIONS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP HAD HELIUM LEAK FROM VALVE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588522 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 N/A.