BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 23741881 · Received December 8, 2025

    Report

    Report Number
    2249723-2025-0004986
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 17, 2025
    Report Date
    February 17, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D9, G3, G6, H2, H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11, E1 (INITIAL REPORTER). . CORRECTED FIELD: E1 (MEDICAL DEVICE ¿ PROBLEM CODE). ADDITIONAL INITIAL REPORTER NAME IS ADDED. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THE ISSUE WAS REPRODUCIBLE. ONE TRAINER CABLE (0012-00-1830-01) WAS REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION ,CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT PROVIDING OUTPUT FOR ARTERIAL PRESSURE AND BALLOON ASSIST PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT PROVIDING OUTPUT FOR ARTERIAL PRESSURE AND BALLOON ASSIST PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422429 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