BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1922695 · Received November 12, 2010

    Report

    Report Number
    1419937-2010-00043
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADD'L F/U WITH THE CUSTOMER, THE PART IS AVAILABLE, BUT SHE HAS NOT SHIPPED IT OUT YET. SHE DID STATE THAT SHE SAW A SPARK, FIRE, AND SMOKE. SHE HAS RECEIVED THE REPLACEMENT TRANSFORMER AND IT IS WORKING FINE. TO DATE, THE CUSTOMER HAS NOT RETURNED THE PART TO MEDELA, AND CURRENT ATTEMPTS TO GET THE PART BACK HAVE BEEN UNSUCCESSFUL. AS THE ORIGINAL PART HAS NOT YET BEEN RETURNED FOR EVAL/INVESTIGATION, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. SHOULD THE PART BECOME AVAILABLE, AN EVAL WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH SUBMITTED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHE HAD A PUMP IN STYLE ADVANCED AND THE POWER CORD CAUGHT ON FIRE. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1