BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 19533206 · Received June 13, 2024

    Report

    Report Number
    2249723-2024-02530
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    June 4, 2024
    Report Date
    February 12, 2025
    Manufacturer
    DATASCOPE CORP.
    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

    UPDATED FIELDS: B4, G3, G6, H2, H6, H10. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1562 REV. E, SN 1614 RAM WITH A REPORTED UNIT FAILURE OF THE FO CONNECTOR HOUSING BEING BROKEN. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A BROKEN CONNECTOR HOUSING. CONFIRMED THE REPORTED FAILURE BUT NO ROOT CAUSE IDENTIFIED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT, INVESTIGATION CONCLUSIONS),H10. THE GETINGE FIELD SERVICE ENGINEER(FSE) THAT DISCOVERED THE ISSUE REPLACED THE CONNECTOR (0012-00-1562) AND PERFORMED FUNCTIONAL AND SAFETY CHECKS TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE GETINGE FIELD SERVICE ENGINEER (GFSE) THAT DURING AN UNRELATED SERVICING OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), THE FIBER OPTIC CONNECTOR WAS DEFECTIVE. THE BLUE HOUSING FROM THE CONNECTOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794703 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose N/A.