BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3970579 · Received June 2, 2014

    Report

    Report Number
    1419937-2014-00462
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    February 10, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVALUATION. A PRODUCT EVALUATION CONFIRMED THE CUSTOMER REPORTED PROBLEM CRACKS IN THE TRANSFORMER HOUSING. THE PRODUCT EVALUATION ALSO REVEALED AC PRONGS OUT OF POSITION TO THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. THIS ISSUE WITH THE DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED ONE OF THE AC PRONGS IS OUT OF POSITION AND ALSO THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.8 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 56.50 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER REPORTED THREE CRACKS IN THE TRANSFORMER HOUSING. DURING THE PRODUCT EVALUATION ON (B)(6) 2014, THE TECHNICIAN OBSERVED A BREACHED TRANSFORMER HOUSING EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321977 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 1613 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1