BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 1883125 · Received October 18, 2010

    Report

    Report Number
    1419937-2010-00028
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR REP CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER OVER THE PHONE. THE TYPE OF TRANSFORMER WAS CONFIRMED. REP HAD THE CUSTOMER TEST THE PUMP WITH THE BATTERY PACK TO SEE IF THE MOTOR WAS STILL WORKING (IT WAS). A REPLACEMENT TRANSFORMER WAS SENT. THE ORIGINAL TRANSFORMER WAS NOT RETURNED FOR FURTHER INVESTIGATION. THEREFORE, NO DEFINITIVE CONCLUSION CAN BE REACHED AS TO THE 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 THE TRANSFORMER STOPPED WORKING. CUSTOMER STATED IT STARTED MELTING AND SMOKING, AND NOW THE MOTOR WON'T TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE PUMP, BREAST, POWERED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1