BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300

    MDR report key: 1564243 · Received December 3, 2009

    Report

    Report Number
    1564243
    Event Type
    Death
    Date Received
    December 3, 2009
    Date of Event
    November 21, 2009
    Report Date
    December 3, 2009
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE BALLOON PUMP WAS IN USE AND AT SOME TIME THE HELIUM ICON DISPLAYED EMPTY BUT THERE WAS NO ALERT OR ALARM DETECTED. THE HELIUM TANKS HAD BEEN FULL AND AT SOME TIME TO FOLLOW THE PRIMARY AND 2 RESERVES TANKS WERE EMPTY. IT WAS DETERMINED THAT A LEAK IN THE REGULATOR CAUSED HELIUM TO ESCAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS300 PUMP, INTRA-AORTIC BALLOON DSP DATASCOPE CORPORATION CS300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death