BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ OX

    MDR report key: 3873699 · Received January 10, 2014

    Report

    Report Number
    3003764448-2014-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    September 19, 2013
    Report Date
    January 10, 2014
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    BYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FDA REPORTED BY MAIL AN ISSUE ASSOCIATED WITH AN EZ OX OXYGEN CONTAINER DISTRIBUTED BY AIR LIQUIDE HEALTHCARE AMERICA CORP. FDA REPORT NUMBER (B)(4). FOLLOW UP BY AIR LIQUIDE WITH THE INITIAL REPORTER INDICATED TWO PATIENT INVOLVED. PATIENT IDENTIFICATION INFORMATION WAS NOT PROVIDED BY THE HC FACILITY SUCH AS AGE, SEX, WEIGHT. THE DEVICE ITSELF IS USED TO CONTAIN AND DELIVER OXYGEN USP TO PATIENT. IN BOTH CASES THE REPORTER INDICATED THAT ON THE OXYGEN OUTLET OF THE DEVICE A BLACK DUST CAP WAS NOT REMOVED AND HOSPITAL PERSONNEL PLACED THE OXYGEN TUBING OVER THE BLACK CAP RESULTING IN INSUFFICIENT FLOW OF OXYGEN TO EACH PATIENT. PATIENT ONE EXPERIENCED A DECLINE IN SPO2. RECOVERED AFTER THE PROPER OXYGEN FLOW WAS APPLIED.

    Description of Event or Problem · 2

    FDA REPORTED BY MAIL AN ISSUE ASSOCIATED WITH AN EZ OX OXYGEN CONTAINER DISTRIBUTED BY AIR LIQUIDE HEALTHCARE AMERICA CORP. FDA REPORT NUMBER (B)(4). FOLLOW UP BY AIR LIQUIDE WITH THE INITIAL REPORTER INDICATED TWO PATIENT INVOLVED. PATIENT IDENTIFICATION INFORMATION WAS NOT PROVIDED BY THE HC FACILITY SUCH AS AGE, SEX, WEIGHT. THE DEVICE ITSELF IS USED TO CONTAIN AND DELIVER OXYGEN USP TO PATIENT. IN BOTH CASES THE REPORTER INDICATED THAT ON THE OXYGEN OUTLET OF THE DEVICE A BLACK DUST CAP WAS NOT REMOVED AND HOSPITAL PERSONNEL PLACED THE OXYGEN TUBING OVER THE BLACK CAP RESULTING IN INSUFFICIENT FLOW OF OXYGEN TO EACH PATIENT. PATIENT TWO REQUIRED INTUBATION. INTUBATION INCREASED LOS AND PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19357 EZ OX EZ OX BYJ AIR LIQUIDE HEALTHCARE AMERICA CORPORATION EZ OX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization
    2