BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIRD

    MDR report key: 1153104 · Received April 29, 2008

    Report

    Report Number
    2021710-2008-00034
    Event Type
    Other
    Date Received
    April 29, 2008
    Date of Event
    October 13, 2006
    Report Date
    April 29, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN 2006, THE USER FACILITY REPORTED THE EVENT TO THE FDA ON 03/07/2008 WHICH WAS OVER 16 MOS FOLLOWING THE EVENT AND THE MFR WAS NOT INFORMED OF THE EVENT UNTIL 03/31/2008 WHICH WAS OVER 17 MOS FOLLOWING THE EVENT. CARDINAL HLTH SENT A LETTER TO THE USER FACILITY REQUESTING A COPY OF THEIR SVC REPORT ASSOCIATED WITH THEIR INSPECTION AND TESTING OF THE DEVICE FOLLOWING THE EVENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. AN INVESTIGATION WAS CONDUCTED BY THIS DEPT. AND IT WAS FOUND THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE END USER HAD CLEARLY INCORRECTLY CONNECTED THE OXYGEN SUPPLY HOSE TO THE PRIMARY OR AUXILLIARY OUTLET OF THE AIR/O2 MIXER. THE PRIMARY AND AUXILLIARY OUTLETS ON THIS DEVICE ARE CLEARLY LABELED AS SUCH AND THE FITTING FOR THESE OUTLETS ARE MALE FITTINGS. IN ORDER FOR THE MALE FITTING ON THE OXYGEN SUPPLY HOSE TO THE CONNECTED TO THE MALE FITTING OF THE PRIMARY OR AUXILIARY OUTLET, AN ADAPTER FITTING MUST BE UTILIZED. THE OXYGEN SUPPLY INLET FOR THIS DEVICE USES FEMALE FITTING AND THUS NO ADAPTER FITTING IS NECESSARY TO CONNECT THE OXYGEN SUPPLY HOSE.

    Description of Event or Problem · 1

    THE OXYGEN SUPPLY HOSE WAS FOUND TO BE CONNECTED TO THE BLENDER 50 PSI HI-FLOW OUTPUT CONNECTION. THIS CONNECTION OF OXYGEN TO THE OUTPUT OF THE BLENDER, CAUSED OXYGEN TO FLOW TO THE LOW-FLOW BLENDER OUTPUT AND WAS ANALYZED AS 50% OXYGEN. WHEN THE HOSE WAS PLACED ON THE INPUT SIDE OF THE BLENDER, IT FUNCTIONED ACCORDING THE MFR'S SPECS." "DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO." "WHAT WAS THE ORIGINAL INTENDED PROCEDURE? OXYGEN ADMIN." "INSPECTION AND TESTED WITH HUDSON OXYGEN MONITOR ON 10/17/2006: IMPROPER OPERATION: WRONG CONNECTION CAUSED THE BLENDER TO DELIVER AN INCORRECT PERCENTAGE OF OXYGEN. THE INLET HOSE WAS CONNECTED TO THE 50 PSI OUTLET BLENDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRD AIR/O2 BLENDER BZR CARDINAL HEALTH 207, INC. BLENDER *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR