BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3050197 · Received April 5, 2013

    Report

    Report Number
    1419937-2013-00195
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN A FOLLOW UP WITH THE CUSTOMER, THE CUSTOMER REPLIED THAT SHE DID NOT WITNESS ANY SMOKE, FIRE, SPARKING, OR MELTING. THE CUSTOMER ALSO INDICATED THERE WAS NO BREACH OF ANY KIND IN THE TRANSFORMER HOUSING. A PRODUCT EVALUATION REVEALED THAT THE CUSTOMER'S COMPLAINT OF A LOOSE PRONG WAS CONFIRMED. IT WAS FOUND TO BE DUE TO THE BREACH IN TRANSFORMER HOUSING. 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. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY AND THE PRONG SUNK INTO THE HOUSING. 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 12.84 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.0 OHMS. THERE WAS NO SHORT CIRCUIT 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 54.43 OHMS, WHICH IS NORMAL AND INDICATES THAT NO THERMAL FUSE WAS BLOWN. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT ONE OF THE PRONGS OF THE ADAPTER "GOES INSIDE THE BOX" OF THE TRANSFORMER WHEN SHE TRIES TO PLUG IT IN. UPON RECEIPT OF THE PRODUCT, A BREACH IN THE TRANSFORMER HOUSING WAS NOTED. THE AWARE DATE HAS BEEN UPDATED TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139801 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/ 9207010 UNK/REV L

    Patients

    Seq Age Sex Outcome Treatment
    1