BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19778370 · Received July 18, 2024

    Report

    Report Number
    2249723-2024-02889
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 28, 2024
    Report Date
    September 6, 2024
    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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6, H10.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9(DEVICE AVAILABLE FOR EVAL), G3, G6, H2, H3, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS), H10, H11 CORRECTED FIELDS: D4(UDI#). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPLACED THE CHASSIS BIN (0441-00-0196) AND THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS.

    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 THAT DURING PRE USE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS CART DAMAGE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554825 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 N/A.