BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ-OX PLUS

    MDR report key: 2142453 · Received December 18, 2007

    Report

    Report Number
    1628496-2007-00001
    Event Type
    Death
    Date Received
    December 18, 2007
    Date of Event
    November 30, 2007
    Report Date
    December 13, 2007
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA
    Product Code
    ECX
    PMA / PMN Number
    K053117
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CONVERSATION BETWEEN (B)(6) AND (B)(6), SHE STATED THAT SHE FELT THE EVENT DID NOT CONTRIBUTE TO THE DEATH OF THE PT. AFTER THE INCIDENT, AIR LIQUIDE HEALTHCARE AMERICA CONDUCTED AN EVALUATION OF THE EZ-OX PLUS DESIGN AND CONCLUDED THAT THERE IS A VERY LOW RISK OF REOCCURRENCE. FIRST, THE DEVICE'S PRODUCT LABEL CONTAINS CLEAR INSTRUCTIONS TO CONNECT THE OXYGEN SUPPLY TUBE TO THE HOSE BARB AND THERE IS ONLY ONE HOSE BARB ON THE DEVICE. SECOND, THE HOSE BARB CONNECTION AND THE DISS CONNECTION USE DIFFERENT FITTINGS. THE HOSE BARB CONNECTION IS THE STANDARD SLIP-ON HOSE BARB COMMONLY FOUND ON HOSPITAL RESPIRATORY THERAPY EQUIPMENT. THE DISS CONNECTION IS A LARGER AND DIFFERENTLY CONFIGURED THREADED CONNECTION. THIRD, THE DISS CONNECTION IS PERMANENTLY LABELED AS "DISS CONNECTION AT 40 LPM". THE INVESTIGATION DETERMINED THAT THE INCIDENT WAS A RESULT OF HUMAN ERROR DURING A HIGH STRESS SITUATION. (B)(4). THIS IS THE ONLY ADVERSE EVENT REPORT RECEIVED BY AIR LIQUIDE HEALTHCARE AMERICA CONCERNING THIS DEVICE.

    Description of Event or Problem · 1

    (B)(6) FROM (B)(6) HOSPITAL IN (B)(6) INFORMED AIR LIQUIDE HEALTHCARE AMERICA AN INCIDENT HAD OCCURRED INVOLVING AN EZ-OX PLUS DEVICE, WHICH IS A PORTABLE OXYGEN DELIVERY SYSTEM CONTAINING OXYGEN USP. AIR LIQUIDE HEALTHCARE AMERICA CONTACTED (B)(6) TO DISCUSS THE INCIDENT AND THE FOLLOWING INFO WAS ACQUIRED: A PT SUFFERED CARDIOPULMONARY ARREST AND THE RESUSCITATION CART CONTAINING AN EZ-OX PLUS WAS BROUGHT TO THE PT. WHEN CONNECTING THE MANUAL RESUSCITATION BAG TO THE EZ-OX PLUS CONTAINER, HOSPITAL PERSONNEL ATTACHED THE TUBING TO THE CONTAINER'S DISS CONNECTION INSTEAD OF THE DEVICE'S BARB CONNECTION. THE EZ-OX PLUS FLOWMETER WAS SET AT 10-LITERS PER MINUTE AND RESUSCITATION EFFORTS PROCEEDED. AFTER A FEW MINS HOSPITAL PERSONNEL NOTICED THE OXYGEN TUBING WAS NOT CONNECTED TO THE DEVICE'S BARB CONNECTION. AFTER A PERIOD OF TIME, THE RESUSCITATION STOPPED BECAUSE THE PT HAD EXPIRED. THE EZ-OX PLUS DEVICE WAS QUARANTINED BY THE DIRECTOR OF RESPIRATORY THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-OX PLUS PORTABLE OXYGEN DELIVERY SYSTEM ECX AIR LIQUIDE HEALTHCARE AMERICA EZ-OX PLUS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death