BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "EZ-OX"

    MDR report key: 863762 · Received March 22, 2007

    Report

    Report Number
    1526809-2007-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 21, 2007
    Manufacturer
    WESTERN/SCOTT FETZER COMPANY
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT IS CURRENTLY IN THE POSSESSION OF THE DISTRIBUTOR. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION BY THE MANUFACTURER. UPON OUR REQUEST, THE DISTRIBUTOR FORWARDED DIGITAL PICTURES OF THE DEVICE FAILURE. IT IS EVIDENT FROM THE PICTURES THAT THE REGULATOR SEPARATED FROM THE ALUMINUM CYLINDER AS REPORTED BY THE DISTRIBUTOR. IT IS ALSO EVIDENT FROM THE NARRATIVE PROVIDED THAT THE CYLINDER WAS PLACED BEHIND THE WHEELCHAIR IN AN UNSUPPORTED / UNSECURED MANNER, WHICH IS CONTRARY TO OPERATING INSTRUCTION PROVIDED WITH THE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED BY THE DISTRIBUTOR: THE CYLINDER WAS WITH A PATIENT ON THE BACK OF THEIR WHEELCHAIR AS THEY WERE BEING MOVED TO THE X-RAY DEPT. THE CYLINDER WAS REMOVED AND PLACED BEHIND THE WHEELCHAIR ONCE AT THE X-RAY DEPT. NO WITNESS OF WHAT OCCURRED NEXT, BUT THE CUSTOMER HYPOTHESIZED THAT THE PATIENT MAY HAVE BACKED UP AND KNOCKED OVER THE CYLINDER. THE REGULATOR HEAD WAS SHEARED OFF THE CYLINDER AT THIS POINT. THE CYLINDER TRAVELED INTO THE WAITING AREA, SPUN AROUND AND EVENTUALLY STOPPED. THE TRAVEL DISTANCE WAS APPROXIMATELY 15 FT. THE GAUGE PRESSURE AND CONTENTS WAS NOT OBSERVED PRIOR TO THIS OCCURRING THEREFORE, THERE IS NO INFO ON THIS, BUT, AGAIN HYPOTHESIZE SINCE THE TRAVEL DISTANCE WAS NOT GREAT, IT WAS NOT A FULL CYLINDER. THE WAITING AREA WHERE THE CYLINDER WENT INTO SHOWED NO SIGNS OF DAMAGE OTHER THAN THE FLOOR WITH SCUFF MARKS. IT WAS REPORTED THAT THE EVENT STARTLED THE PATIENT INVOLVED CAUSING HIM TO FALL. THE PATIENT SUFFERED MINOR BRUISES FROM HIS FALL. NO OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "EZ-OX" PORTABLE OXYGEN SYSTEM CAW WESTERN/SCOTT FETZER COMPANY ALQ-1967 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other