BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3932840 · Received March 11, 2014

    Report

    Report Number
    1419937-2014-00260
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. PRODUCT RECEIVED AND EVALUATED BY QE AND CONFIRMED A BREACH IN THE TRANSFORMER HOUSING. MEDELA ACKNOWLEDGES THAT THIS REPORT IS BEING SUBMITTED LATE. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING. THIS ISSUE WITH THE 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. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 13.03 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 55.50 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO CUSTOMER SERVICE THE TRANSFORMER FOR HER PUMP IN STYLE TRANSFORMER WOULD NOT POWER THE DEVICE. UPON RECEIPT OF THE PRODUCT AND THE QE EVALUATION, A BREACH WAS FOUND IN THE TRANSFORMER HOUSING WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146332 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 9207010/57063 REV M/1712

    Patients

    Seq Age Sex Outcome Treatment
    1