BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22121726 · Received June 2, 2025

    Report

    Report Number
    2249723-2025-0002413
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 19, 2025
    Report Date
    October 28, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, E1 EVENT SITE MAIL, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS), H11. ADDITIONAL POINT OF CONTACT NAME TOM TOTH, PHONE : (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED ALL COMPONENTS RELATED TO HELIUM LEAK. THE HIGH PRESSURE LINE, HELIUM FILL MANIFOLD, QUICK CONNECT, ANALOG PRESSURE GAUGE AND CHECKED ALL CONNECTIONS, BUT THE SYSTEM STILL SHOWS A LEAK. THE LEAK WAS WITHIN THE OEM STANDARDS BUT THE CUSTOMER REQUESTED A RETURN VISIT. THE FSE STATED THAT DURING HIS RETURN, REQUESTED BY THE CUSTOMER, THAT FSE WOULD BRING A HELIUM SNIFFER AND REFILL STATION FOR FURTHER TESTING. THE SYSTEM PRESENTED A HELIUM LEAK USING ION SCIENCE LTD GASCHECK 19-01558. THE HELIUM SNIFFER LOCATED LEAK IN CONSOLE AND CART. THE FSE REPLACED THE FILL MANIFOLD ASSEMBLY, HELIUM LINES IN CART AND CONSOLE AND HIGH PRESSURE HELIUM REGULATOR. THE LEAK WAS REMEDIED AND BROUGHT WELL WITHIN OEM SPECIFICATIONS. THE FSE ALSO FOUND DURING TESTING WITH SNIFFER THAT AIR GAS PROVIDED HELIUM TANK HAS A FAULTY VALVE. THE FSE NOTIFIED THE STAFF OF THE PROBLEM. ADDITIONAL GFES HAVE BEEN PERFORMED TO OBTAIN FURTHER INFORMATION. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11 CORRECTED FIELDS: H6 (COMPONENT CODES).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA AORTIC BALLOON PUMP IS LEAKING HELIUMAND GOING THROUGH 1-2 TANKS. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27879 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 UNKNOWN.