BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 7135163 · Received December 20, 2017

    Report

    Report Number
    1419937-2017-00356
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    April 1, 2016
    Report Date
    December 20, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. A BREACH IN THE POWER SUPPLY HOUSING WAS IDENTIFIED DURING EVALUATION OF THE RETURNED PRODUCT. THIS ISSUE WITH A DAMAGED REV L POWER SUPPLY FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THEY WERE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE WAS CAUSING THE PLASTIC HOUSING TO FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER TO SHIP THE POWER SUPPLY TO MEDELA WAS 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 WAS MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH WAS ALSO INCREASED TO FURTHER PROTECT THE POWER SUPPLY DURING SHIPPING. SINCE THEN, AS A PART OF ROUTINE CONTINUOUS IMPROVEMENT ACTIVITIES, A REV P POWER SUPPLY HAS BEEN DISTRIBUTED TO MARKET, MANUFACTURED UNDER A REVISED DESIGN AND BY A DIFFERENT MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CUSTOMER REPORTED TO MEDELA LLC THE POWER SUPPLY FOR HER PUMP IN STYLE GO TOTE BREAST PUMP HAD EXPOSED WIRES ON THE CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915872 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA LLC 57063 9207010-REV L-0912

    Patients

    Seq Age Sex Outcome Treatment
    1