BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIPURE

    MDR report key: 2474156 · Received February 23, 2012

    Report

    Report Number
    2474156
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 22, 2012
    Manufacturer
    PRAXAIR, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    CYLINDER WAS PAINTED WITH THE INDUSTRY STANDARD COLOR OF BLUE (NITROUS OXIDE) INSTEAD OF GREEN (OXYGEN). PAPER LABEL FOR CONTENTS OF THE CYLINDER LABELED AS OXYGEN. VALVE STEM ON THE CYLINDER WAS PIN INDEXED FOR THE INDUSTRY STANDARD TO ALLOW AN OXYGEN REGULATOR.======================MANUFACTURER RESPONSE FOR MEDIPURE MEDICAL GAS CYLINDER (PER SITE REPORTER).======================MANUFACTURER WILL CONDUCT THE ANALYSIS OF THE CONTENTS OF THE CYLINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIPURE MEDICAL GAS CYLINDER CAN PRAXAIR, INC. UN1072 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *