BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 3880979 · Received April 7, 2014

    Report

    Report Number
    1419937-2014-00340
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVALUATION. THE DEFECTIVE POWER ADAPTER HAS NOT BEEN RECEIVED AT MEDELA AS OF 04/01/2014. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. CUSTOMER FOLLOW UP WAS NOT SUCCESSFUL. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP WILL BE FILED AT THAT TIME. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS CURRENT BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER TRANSFORMER HOUSING FELL APART EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207047 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX HGX MEDELA, INC. 57062/9207010 5012 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1