BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 20171533 · Received September 9, 2024

    Report

    Report Number
    2249723-2024-03695
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 20, 2024
    Report Date
    May 12, 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 RESTRICTIONS IN BLOCK E1 TELEPHONE NUMBER : (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E1 EVENT SITE TELEPHONE, G3, G6, H2, H3, H4, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, H11. CORRECTED FIELDS: B5. THE CUSTOMER CONFIRMED THE FAULT WAS DO TO WITH THE FSM. ENGINEER ATTENDED TO COMPLETE THE FSM INSTEAD. NO FURTHER INFORMATION IS AVAILABLE IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS GIVING AN ERROR. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) UNIT IS GIVING AN ERROR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021966 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