BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIDELITY

    MDR report key: 1301392 · Received January 26, 2009

    Report

    Report Number
    1301392
    Event Type
    Malfunction
    Date Received
    January 26, 2009
    Date of Event
    December 31, 2008
    Report Date
    January 26, 2009
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDELITY CATHETER, INTRA-AORTIC BALLOON DSP DATASCOPE CORPORATION * 2060

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR