BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3843564 · Received March 25, 2014

    Report

    Report Number
    1419937-2014-00301
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 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

    UPON RECEIPT OF THE PRODUCT AN EVALUATION SHOWED THAT THE HOUSING WAS BREACHED, EXPOSING INTERNAL ELECTRONICS, WHICH IS A SAFETY RISK. 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 PRODUCT THE TRANSFORMERS DURING SHIPPING. THIS CORRECTION ACTION APPLIES TO TRANSFORMERS WITH A DATE CODE GREATER THAN OR EQUAL TO 3912. COMPLAINT DATA TRENDING WILL CONTINUE TO BE MONITORED BY MEDELA QUALITY MANAGEMENT FOR INVESTIGATION/CAPA CONSIDERATION. POSSIBLE RESOLUTIONS PROVIDED TO CUSTOMER. REPLACEMENT PRODUCT OR ONLINE ORDERING INFORMATION. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY AND THERE WAS A LOOSE PRONG. 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 AT 54.6 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED TO CUSTOMER SERVICE THAT HER PUMP IN STYLE WOULD NOT POWER ON WITH EITHER POWER SOURCE. UPON RECEIPT OF THE PRODUCT AT MEDELA THE PUMP WAS FOUND TO HAVE A BROKEN DC JACK. THE TRANSFORMER WAS FOUND TO HAVE A BREACHED TRANSFORMER HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174236 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA INC 57063/9207010 REV M-4112

    Patients

    Seq Age Sex Outcome Treatment
    1