BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3072646 · Received April 19, 2013

    Report

    Report Number
    1419937-2013-00226
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT WITNESS ANY SMOKE, FIRE, OR SPARKING. CUSTOMER STATED SHE WAS UNPLUGGING THE POWER SUPPLY FROM A POWER STRIP WHEN IT CAME APART. CUSTOMER ALSO STATED NO INJURIES WERE SUSTAINED. A PRODUCT EVALUATION REVEALED THAT THE TRANSFORMER HOUSING WAS BROKEN, EXPOSING INNER ELECTRONICS, WHICH IS SAFETY RISK. SEE PAGE 3 FOR DETAILS ON THE TRANSFORMER. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THE TRANSFORMERS ARE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE IS CAUSING THE PLASTIC HOUSING TO FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER TO SHIP THE TRANSFORMERS TO MEDELA IS NOT ROBUST ENOUGH TO HANDLE ALL OF THE POTENTIAL SHIPPING, HANDLING, AND ABUSE CONDITIONS THAT COULD ARISE FROM LOGISTICS OF THE CONSOLIDATION PROCESS. AS A RESULT OF THE INVESTIGATION, THE SHIPPING AND CONSOLIDATION PROCESS HAS BEEN MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE WIRE ON THE POWER SUPPLY FOR THEIR BREAST PUMP WAS LOOSE. UPON RECEIPT OF THE PRODUCT, A BREACH IN THE TRANSFORMER HOUSING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169809 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV L/0912

    Patients

    Seq Age Sex Outcome Treatment
    1