BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 4200155 · Received October 21, 2014

    Report

    Report Number
    1419937-2014-00795
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 17, 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

    PRODUCT WAS RECEIVED ON (B)(4) 2014 AND EVALUATED ON (B)(4) 2014 BY QE AND A BREACH IN THE TRANSFORMER HOUSING WAS DISCOVERED. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). 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 POWER SUPPLY WAS NOT PLUGGED IN SO THE VOLTAGE ACROSS THE DC PLUG WAS NOT MEASURED. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.770 M OHMS, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 54.8, WHICH IS NOT NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO ORIGINALLY REPORT THAT HER TRANSFORMER HOUSING HAD A CRACK. UPON RECEIPT OF THE PRODUCT AND A QE EVALUATION ON (B)(4) 2014, A BREACH IN THE TRANSFORMER HOUSING WAS OBSERVED WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670237 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV N-1313

    Patients

    Seq Age Sex Outcome Treatment
    1