BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP BACKPACK

    MDR report key: 1883119 · Received October 18, 2010

    Report

    Report Number
    1419937-2010-00034
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 15, 2010
    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

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER AND THE ORIGINAL RETURNED FOR EVALUATION/INVESTIGATION. RESULTS OF THE EVALUATION BY THE MANUFACTURER INDICATED AN ISSUE WAS FOUND WITH THE PC BOARD, BUT NO ADDITIONAL DETAILS WERE RECORDED. THE PUMP IS NO LONGER AVAILABLE FOR FURTHER INVESTIGATION. THEREFORE, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED PRODUCT 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 SHE PURCHASED THE PUMP IN (B)(6). ON (B)(6) 2010, SHE WAS USING THE BATTERY PACK WHEN THE MACHINE STARTED TO SMOKE AND SMELL LIKE SOMETHING WAS BURNING. SHE UNPLUGGED IT, BUT IT WILL NOT WORK WITH THE ADAPTOR OR BATTERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1