BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19469187 · Received June 5, 2024

    Report

    Report Number
    2249723-2024-02364
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 23, 2024
    Report Date
    February 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    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, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT, INVESTIGATION CONCLUSIONS),H11.THE GETINGE SERVICE TERRITORY MANAGER (STM) THAT DISCOVERED THE ISSUE REPLACED THE HINGE TO RESOLVE THE ISSUE. UNIT PASSES ALL TESTS AND CALIBRATIONS TO MANUFACTURER STANDARD AND IS RELEASED FOR CLINICAL USE. THE FOLLOWING WAS PERFORMED BY FAILURE ANALYSIS AND TESTING DEPT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED PART NUMBER 0105-00-0138-02 HINGE SERIAL NUMBER: N/A WITH A REPORTED UNIT FAILURE OF BROKEN DISPLAY HINGE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF THE PART RECEIVED AND FOUND THAT THE HINGE PART NUMBER 0105-00-0138-02 IS BROKEN. DUE TO THE BROKEN HINGE, THE FAT DEPT. CANNOT INSTALL AND INVESTIGATE ANY FURTHER. RETAINING THE HINGE IN THE FAILURE ANALYSIS AND TESTING DEPT. PER PROCEDURE.

    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) UNIT HAS A BROKEN DISPLAY HINGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806436 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown