BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART OMNILINE GUARDIAN O2

    MDR report key: 2869667 · Received December 10, 2012

    Report

    Report Number
    8044004-2012-00002
    Event Type
    Other
    Date Received
    December 10, 2012
    Date of Event
    July 1, 2012
    Report Date
    September 23, 2012
    Manufacturer
    ORIDION MEDICAL 1987 LTD.
    Product Code
    CCK
    PMA / PMN Number
    K093388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S PRELIMINARY ANALYSIS DETERMINED THAT KINKING OF THE O2 TUBING MAY HAVE REDUCE O2 FLOW TO THE PATIENT AND AS A RESULT MAY HAVE AFFECTED PATIENT OXYGEN SATURATION OF BLOOD. THE FOLLOWING CORRECTIVE ACTIONS/PREVENTIVE ACTIONS WERE IMPLEMENTED BY THE MANUFACTURER: SUGGEST THE END USER TO USE THE LONG VERSION OF THE PRODUCT (4 METERS) TO AVOID OVERSTRETCHING THAT MAY RESULT IN KINKING. UPDATE THE DIRECTIONS FOR USE OF THE PRODUCT WITH DIRECTIONS TO PREVENT THIS ISSUE.

    Description of Event or Problem · 1

    PATIENT DURING UPPER ENDOSCOPY WAS MONITORED WITH SMART CAPNOLINE GUARDIAN, WHICH IS USED FOR CO2 MONITORING AND O2 DELIVERY DURING UPPER ENDOSCOPY. PATIENT BEGAN TO EXHIBIT OXYGEN DESATURATION OF BLOOD (AS INDICATED BY PULSE OXIMETRY) DURING THE PROCEDURE. PHYSICIAN FELT THAT THE DESATURATION MAY HAVE BEEN AFFECTED BY A KINK IN THE O2 TUBING OF THE GUARDIAN DEVICE; HE FELT THAT THE KINK WAS CAUSED BY OVER-STRETCHING OF THE O2 TUBING. THE PHYSICIAN ADJUSTED THE O2 TUBING, FOLLOWING WHICH O2 SATURATION OF BLOOD RETURNED TO ACCEPTABLE LEVELS. IT IS NOT CLEAR IF THE DESATURATION WAS CAUSED BY OR AFFECTED BY THE DEVICE OR IF IT WAS DUE TO PATIENT FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART OMNILINE GUARDIAN O2 CCK ORIDION MEDICAL 1987 LTD. 012531 Q1205088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other