BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 22662634 · Received July 30, 2025

    Report

    Report Number
    2249723-2025-0003244
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 15, 2025
    Report Date
    September 16, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, B6, B7, D9, D10, E1(INITIAL REPORTER, EVENT SITE EMAIL), G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, HEALTH EFFECT ¿ IMPACT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE REPLACED THE AC POWER CORD REEL (D012-00-1688-24), THE CART BULK POWER SUPPLY (D014-00-0258) TO RESOLVE THE ISSUE AND IMPLEMENTED THE FA358 AND UNIT TESTED TO BE OK. THE FSE ALSO NOTICED THAT THE THERMAL ARRAY CHART PAPER NEEDS TO BE REPLACED (D683-00-0422-02) SO HE REPLACED IT. THE THERMAL PAPER WILL BE CHARGED TO GETINGE SERVICE AS THIS IS FOR INTERNAL TESTING PURPOSES. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION E1 EVENT SITE NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-USE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT ABLE TO CHARGE. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NOT ABLE TO CHARGE. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49796 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 N/A NOT REQUIRED FOR HARDWARE 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| UNKNOWN.