BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 16264671 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00718
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    March 8, 2022
    Report Date
    March 5, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    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. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA 584165.

    Additional Manufacturer Narrative · 0

    ADDITIONAL POINT OF CONTACT NAME: MR. (B)(6). E-MAIL ADDRESS: (B)(6). DEPARTMENT: MID. OCCUPATION: BIOMEDICAL ENGINEER. THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE RIGHT HINGE DISPLAY (0105-00-0138-02) AND COMPLETED THE PM WITH FULL CALIBRATION, FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN HINGE FROM THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3011 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown