BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19311968 · Received May 14, 2024

    Report

    Report Number
    2249723-2024-01998
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    May 1, 2024
    Report Date
    February 4, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E1 (EVENT SITE POSTAL CODE - 609606), G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER EVALUATED AND REPLACED THE PARTS SCREW (D212-17-0604), DOPPLER (D406-00-0947), STORAGE BIN (D380-00-0539) AND FOUND THAT AN ADDITIONAL PART IS REQUIRED. NO FURTHER INFORMATION AVAILABLE. IF ANY PERTINENT INFORMATION AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE CUSTOMER HAS NOT REQUESTED GETINGE TO REPAIR THE IABP AND ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER WITH REGARD TO THE REPAIR AND STATUS OF THE IABP; HOWEVER, DESPITE OUR BEST EFFORTS, NO REPAIR INFORMATION AND NO STATUS OF THE IABP HAS BEEN RECEIVED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : UNKNOWN.

    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

    CORRECTED SECTION: H3. UPDATED SECTIONS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION), H10, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) A SCREW ON THE DOOR IN WHICH THE DOPPLER IS HOUSED WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474843 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