BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 3083189 · Received April 29, 2013

    Report

    Report Number
    2015691-2013-19937
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT BEING RETURNED FOR EVALUATION. WITHOUT RETURN OF THE PRODUCT, THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. IT IS UNKOWN IF DAMAGES OR DEFECT EXISTED ON THE PRODUCT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE TUBE WAS FOUND BROKEN/SEPARATED. THE TUBING WAS SHEARED RIGHT AT THE CONNECTOR PART THAT BONDS WITH THE TUBE. AS REPORTED, THE TUBING WAS COMPLETELY SEPARATED FROM THE DEVICE, WHILE THE TUBING END WAS OBSERVED TO BE SMOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183613 PHOENIX DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T001631A 59401044

    Patients

    Seq Age Sex Outcome Treatment
    1