BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE WIC BREAST PUMP W/O BATTERY

    MDR report key: 3727231 · Received January 24, 2014

    Report

    Report Number
    1419937-2014-00121
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    August 8, 2013
    Report Date
    January 21, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVALUATION. THE DEFECTIVE POWER ADAPTER WAS RECEIVED AT MEDELA ON 09/14/2013. A PRODUCT EVALUATION WAS UNABLE TO CONFIRM CUSTOMER REPORTED PROBLEM BUT HAD REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY WHICH IS A SAFETY RISK. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION IR 12-0037. 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 TRANSFORMER 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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE POWER ADAPTER FELT HOT TO THE TOUCH. DURING THE PRODUCT EVALUATION ON 12/26/13, THE TECHNICIAN OBSERVED A DAMAGED TRANSFORMER HOUSING - BREACH PRESENT, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55890 PUMP IN STYLE WIC BREAST PUMP W/O BATTERY HGX MEDELA, INC. 57018W/9207010 1112 REV L

    Patients

    Seq Age Sex Outcome Treatment
    1