BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 4946725 · Received July 28, 2015

    Report

    Report Number
    1419937-2015-00236
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER HOUSING ON HER ADVANCED PERSONAL DOUBLE BREAST PUMP BROKE OPEN, EXPOSING THE INNER CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489492 BP ADVANCED PERSONAL DOUBLE HGX HGX MEDELA INC. 57065/9207010 REV N - 0813

    Patients

    Seq Age Sex Outcome Treatment
    1