BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1883118 · Received October 18, 2010

    Report

    Report Number
    1419937-2010-00035
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER. THE ORIGINAL TRANSFORMER WAS NOT OBTAINED FOR EVALUATION BY THE MANUFACTURER. 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 THE PUMP IS FIVE MONTHS OLD. THE AC/ADT BECAME HOT AND STARTED SMOKING. NO INJURIES WERE REPORTED, AND NO DAMAGE TO THE OUTLET WAS NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1