BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3955631 · Received June 13, 2014

    Report

    Report Number
    1419937-2014-00489
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS RETURNED FOR EVALUATION AND WAS DETERMINED TO BE BREACH, WHICH IS A SAFETY RISK. 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 RESULTS 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. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC WAS MEASURED AT 12.8. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. THE RESISTANCE ACROSS THE AC BLADES MEASURED AT 55.1 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 PRONGS ON HER TRANSFORMER PUSHES BACK INTO THE ADAPTER. WHEN THE PRODUCT WAS RECEIVED AT MEDELA, THE TRANSFORMER WAS DETERMINED TO BE BREACH, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350647 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV M-5012

    Patients

    Seq Age Sex Outcome Treatment
    1