BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCES BREAST PUMP GO TOTE

    MDR report key: 4102218 · Received September 17, 2014

    Report

    Report Number
    1419937-2014-00711
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEFECTIVE POWER ADAPTER WAS RECEIVED AT MEDELA ON (B)(4) 2014 AND EVALUATED ON (B)(4) 2014. A PRODUCT EVALUATION CONFIRMED THE CUSTOMER REPORTED PRONG ISSUE. THE PRODUCT EVALUATION ALSO REVEALED THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS CURRENTLY BEING INVESTIGATED UNDER IR13-0154. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED A DAMAGED PRONG AND THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 13.40 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 56.5 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 TO MEDELA CUSTOMER SERVICE THAT THE POWER ADAPTER DROPPED ON THE GROUND AND THE PRONGS WERE PUSHED INTO TRANSFORMER HOUSING. DURING THE PRODUCT EVALUATION ON (B)(4) 2014, THE TECH OBSERVED A DAMAGED PRONG AND A BREACHED TRANSFORMER HOUSING EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577180 PUMP IN STYLE ADVANCES BREAST PUMP GO TOTE HGX HGX MEDELA, INC. 57063/9207010 1413 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1