BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3970587 · Received June 2, 2014

    Report

    Report Number
    1419937-2014-00456
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 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

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. PRODUCT RECEIVED AND EVALUATED BY QE AND CONFIRMED A BREACH IN THE TRANSFORMER HOUSING. 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 PACKAGE 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 12.7 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 57.9 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE WIRES ON THE TRANSFORMER OF HER PUMP IN STYLE BREAST PUMP WERE EXPOSED. HOWEVER, WHEN THE PRODUCT WAS RECEIVED AND EVALUATED BY QE A BREACH IN THE TRANSFORMER EXPOSING THE UNDERLYING ELECTRONICS WAS FOUND. THIS IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322111 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 9207010/57063 2011/REV L

    Patients

    Seq Age Sex Outcome Treatment
    1