BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 805829 · Received December 15, 2006

    Report

    Report Number
    805829
    Event Type
    Malfunction
    Date Received
    December 15, 2006
    Date of Event
    November 1, 2006
    Report Date
    December 15, 2006
    Manufacturer
    PRAXAIR, INC.
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON AN INTRA AORTIC BALLOON PUMP. THE PUMP ALARMED LOW HELIUM. WHEN THE NURSE WENT TO PUT ON A NEW, SEALED, HELIUM TANK IT WAS EMPTY. THERE WERE TWO OTHER SEALED HELIUM TANKS THAT UPON INSPECTION ONE WAS FOUND EMPTY AND ONE THAT WAS PARTIALLY FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TANK, HELIUM ECX PRAXAIR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *