BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 4260942 · Received November 15, 2014

    Report

    Report Number
    1419937-2014-00859
    Event Type
    Malfunction
    Date Received
    November 15, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 7, 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 TO BE RETURNED FOR EVALUATION. THE DEFECTIVE POWER ADAPTER WAS RECEIVED AT MEDELA ON 01/11/2014. A PRODUCT EVALUATION CONFIRMED THE CUSTOMER REPORTED PROBLEM AS BOTH AC PRONGS ARE OUT OF POSITION. THE PRODUCT EVALUATION ALSO REVEALED THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. THIS ISSUE WITH REVISION N DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED BOTH PRONGS WERE OUT OF POSITION AND THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE TECHNICIAN WAS UNABLE TO PERFORM VOLTAGE ACROSS THE DC PLUG TEST DUE TO THE CONDITION OF THE POWER ADAPTER. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AS 215 K OHM, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 58.6 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE CUSTOMER REPORTED TO MEDELA CUSTOMER SERVICE THAT HER PUMP IN STYLE POWER ADAPTER PRONGS WERE LOOSE. DURING THE PRODUCT EVALUATION ON 10/31/2014, 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
    740407 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 0813 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1