BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIDELITY

    MDR report key: 1061699 · Received May 22, 2008

    Report

    Report Number
    1061699
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 22, 2008
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLOOD WAS NOTED IN THE IABP TUBING. PATIENT'S BP STABLE AT ALL TIMES. IABP WAS IMMEDIATELY TURNED OFF. THE BALLOON WAS REMOVED AND PRESSURE APPLIED. THE IABP WAS GOING TO BE REMOVED THAT DAY ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDELITY CATHETER, IABP DSP DATASCOPE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR