BEUDAMED
    FDA Adverse Event Other Summary report: N

    EZ-OX

    MDR report key: 1564883 · Received December 21, 2009

    Report

    Report Number
    MW5014085
    Event Type
    Other
    Date Received
    December 21, 2009
    Date of Event
    December 16, 2009
    Report Date
    January 4, 2010
    Manufacturer
    WESTERN MEDICA
    Product Code
    CAN
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUPPLEMENTAL INFO REGARDING THE FORM 3500 MDR SUBMITTED ON 12/21/09: THE EZ-OX CYLINDER WHICH WAS THE SUBJECT OF MDR WAS NOT USED IN ACCORDANCE WITH ITS LABELING INSTRUCTIONS.

    Description of Event or Problem · 1

    IN 2009: A PT CONNECTED TO AN EZ-OX CYLINDER WAS BEING MOVED FROM THE OR TO ANOTHER DEPARTMENT. ANESTHESIOLOGIST WHO HAD CONNECTED THE PT TO THE EZ-OX AND WAS ACCOMPANYING PT NOTICED THAT THE PT'S BLOOD OXYGEN LEVEL, WHICH SHOULD HAVE BEEN OVER 92, WAS 60. FACILITY FOUND NO OXYGEN WAS FLOWING FROM THE EZ-OX, REMOVED THE EZ-OX AND CONNECTED THE PT TO FACILITY'S CENTRALIZED, PIPED OXYGEN SUPPLY. ADVISED THAT THE PT WAS FINE. THERE WAS NO FLOW FROM EZ-OX BECAUSE THE FLOW SELECTOR WAS NOT SET IN A FLOW POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-OX METAL CYLINDER WITH INTEGRATED REGULATOR CONTAINING OXYGEN USP CAN WESTERN MEDICA EZ-OX 309ANC9018C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other