BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 6168044 · Received December 12, 2016

    Report

    Report Number
    1419937-2016-00317
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 12, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER ADAPTER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS DISCARDED BY THE CUSTOMER. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THE CAUSE OF THE BREACH IN THE REV P TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CUSTOMER SERVICE ON (B)(6) 2016, THAT SHE HAD DROPPED HER POWER ADAPTER TO HER PUMP IN STYLE ADVANCED GO TOTE. THE POWER ADAPTER BROKE OPEN EXPOSING THE INNER CIRCUITRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818843 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA INC 9207010/57063 REV P - UNK

    Patients

    Seq Age Sex Outcome Treatment
    1