BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ORIGINAL BREAST PUMP

    MDR report key: 3801969 · Received February 14, 2014

    Report

    Report Number
    1419937-2014-00179
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A BREACH IN THE TRANSFORMER HOUSING, WHICH IS A SAFETY RISK. A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. F/U WITH THE CUSTOMER IS ONGOING AND INCOMPLETE. SHOULD ADD'L INFO OR THE ORIGINAL DEVICE BE REC'D RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER ADAPTER FOR HER PUMP IN STYLE DEVICE WAS BROKEN AND THE INNER COILS WERE OUT OF THE TRANSFORMER HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97807 PUMP IN STYLE ORIGINAL BREAST PUMP HGX MEDELA, INC. 57040/9207010 14C

    Patients

    Seq Age Sex Outcome Treatment
    1