BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 2803159 · Received October 19, 2012

    Report

    Report Number
    1419937-2012-00650
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER. ATTEMPTS TO CONTACT THE CUSTOMER FOR FOLLOW UP AND FOR PRODUCT RETURN WERE UNSUCCESSFUL. THE REV AND LOT FOR THIS TRANSFORMER WERE UNK AS OF THE DATE OF THIS REPORT. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE ORIGINAL PRODUCT OR ADDITIONAL INFO BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED AT THE TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER CORD FOR THEIR PUMP IN STYLE DEVICE SPARKED AND HAD A FUNNY SMELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1