BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 2772219 · Received October 4, 2012

    Report

    Report Number
    2015691-2012-18395
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. AT THIS TIME THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE PRODUCT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE PRODUCT EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ONE SINGLE DPT KIT WAS RETURNED FOR EVALUATION IN A SEALED ORIGINAL PACKAGE. AS RECEIVED, THE PACKAGE WAS INTACT. NO VISIBLE DAMAGE WAS OBSERVED ON THE TYVEK OR CLEAR PLASTIC PART OF THE PACKAGING. THE SEAL AROUND THE PACKAGE WAS ALSO INTACT. THE SEAL (HEAT TRANSFER) APPEARED COMPLETE. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. THE VISUAL EXAMINATION WAS PERFORMED UNDER 10X MAGNIFICATION. THE COMPLAINT WAS NOT CONFIRMED. THE PACKAGE WAS INTACT AND THERE WAS NO STERILITY BREACH. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING "IS ALLOWING AIR TO COME OUT". THE REPORTER STATED THAT NO DAMAGE OR HOLE WAS VISIBLE AND THAT THE SEAL APPEARED INTACT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX DISPOSABLE PRESSURE TRANSDUCER TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T001642A 59215950

    Patients

    Seq Age Sex Outcome Treatment
    1