BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 20096483 · Received August 29, 2024

    Report

    Report Number
    2249723-2024-03529
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 8, 2024
    Report Date
    March 3, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE UPPER HINGE COVER DISPLAYS (0380-00-0561 X2), THE LEFT DISPLAY HINGE (0105-00-0138-01), AND THE RIGHT DISPLAY HINGE (0105-00-0138-02). THE FSE COMPLETED THE PM WITH FUNCTIONAL AND SAFETY CHECKS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4; G3; G6; H2; H6 (INVESTIGATION FINDINGS); H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UPPER-DISPLAY IS DIFFICULT TO OPEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766575 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown