BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 3071432 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19877
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    ONE SINGLE DPT WAS RETURNED FOR EVALUATION. THE PRESSURE TUBING WAS FOUND DETACHED FROM THE SOLVENT BOND JOINT WITH DISTAL SAMPLE SITE. INDICATION OF BONDING SOLVENT WAS PRESENT ON A SMALL PART OF THE TUBING BOND AREA. THERE WAS NO RESIDUAL BONDING SOLVENT PRESENT AT THE SAMPLE SITE TUBE HOUSING. IT APPEARED THAT THE TUBING DETACHMENT MIGHT HAVE BEEN CAUSED BY INADEQUATE BONDING SOLVENT AT THE BOND JOINT. AN INVESTIGATION IS CURRENTLY OPEN TO DETERMINE THE ROOT CAUSE OF THE DETACHMENT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    AS REPORTED, THE PRESSURE TUBING DETACHED FROM THE Z-SITE DURING USE IN SURGERY. SOME BLEEDING OCCURRED (QUANTITY NOT SPECIFIED) BUT NO ACTUAL INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171478 PHOENIX DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T005021G 59386841

    Patients

    Seq Age Sex Outcome Treatment
    1