BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION 7FR, THE CS 300 WITH INTELLISENSE

    MDR report key: 3213143 · Received July 1, 2013

    Report

    Report Number
    3213143
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 9, 2013
    Manufacturer
    DATASCOPE
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON PUMP ALARMED AND RN FOUND PUDDLE OF IV FLUID ON FLOOR NEAR INTRA AORTIC BALLOON PUMP AND BALLOON PUMP COMPLETELY OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298010 SENSATION 7FR, THE CS 300 WITH INTELLISENSE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention