BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS 100 INTRA-AORTIC BALLOON PUMP

    MDR report key: 863102 · Received May 23, 2007

    Report

    Report Number
    863102
    Event Type
    Injury
    Date Received
    May 23, 2007
    Date of Event
    May 14, 2007
    Report Date
    May 23, 2007
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    MACHINE NEVER ALARMED, AS WITNESSED BY THE NURSE IN THE ROOM. IT WAS NOTED THAT THE ENTIRE CLEAR TUBING QUICKLY FILLED WITH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS 100 INTRA-AORTIC BALLOON PUMP PUMP, IABP DSP DATASCOPE CORPORATION CS 100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention