BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 22529515 · Received July 17, 2025

    Report

    Report Number
    2249723-2025-0003065
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Report Date
    September 8, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1, EVENT SITE TELEPHONE IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G1, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: E1 (INITIAL REPORTER, EVENT SITE MAIL). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, REPLACEMENT REGULATOR (0103-00-0637) IS NEEDED TO COMPLETE REPAIR. HISSING SOUND WHEN HELIUM BOTTLE IS OPENED. REPLACED HIGH PRESSURE REGULATOR (0103-00-0637). OPENED BOTTLE AND NO LEAK HEARD. LEAK TESTS PASSED. ALL CHECKS PERFORMED AND SEEN TO PASS. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER DURING CHECK THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THAT HELIUM WAS LEAKING FROM REGULATOR ONCE BOTTLE WAS CHANGED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672353 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown