BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 4152501 · Received October 6, 2014

    Report

    Report Number
    1419937-2014-00763
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 EVAL. THE DEFECTIVE POWER ADAPTER WAS RECEIVED AT MEDELA ON (B)(6) 2014. A PRODUCT EVAL WAS UNABLE TO CONFIRM CUSTOMER REPORTED EXPOSED WIRES ON POWER ADAPTER BUT HAD REVEALED THE TRANSFORMER HOUSING WAS BREACHED ON (B)(6) 2014, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE TECH WAS UNABLE TO PERFORM THE VOLTAGE ACROSS THE DC PLUG TEST DUE TO PRONGS BEING OUT OF POSITION. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. THE RESISTANCE ACROSS AC BLADES MEASURED AS 55.2 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER EMAILED TO MEDELA CUSTOMER SVC THAT HER POWER CORD WAS BROKEN. ON (B)(6) 2014, THE CUSTOMER CALLED MEDELA CUSTOMER SVC AND STATED HER POWER ADAPTER HAD EXPOSED WIRES. DURING THE PRODUCT EVAL ON (B)(6) 2014, THE TECH 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
    622275 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 1313 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1