BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1883120 · Received October 18, 2010

    Report

    Report Number
    1419937-2010-00032
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER; THE ORIGINAL PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, NO DEFINITIVE CONCLUSION CAN BE REACHED REGARDING THE ROOT CAUSE OF THE REPORTED PROBLEM. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FOR THE PAST TWO DAYS (8/2 AND 8/3), THE AC ADAPTER FOR THE PUMP SEEMED TO OVER HEAT, AND HAS NOW STOPPED WORKING COMPLETELY. WHENEVER IT IS PLUGGED INTO AN OUTLET (WHETHER IN USE OR JUST PLUGGED IN WITHOUT BEING TURNED ON), IT BECOMES HOT TO THE TOUCH, AND THE EXTERNAL PLASTIC COVERING IS NOW STARTING TO MELT. THE CUSTOMER HAS STOPPED USING THE TRANSFORMER AND IS ONLY USING THE BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED NONE HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1