BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 3181867 · Received June 17, 2013

    Report

    Report Number
    1419937-2013-00319
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, THE CUSTOMER REPORTED THAT THEIR POWER ADAPTER FELL COMPLETELY APART, EXPOSING THE INNER ELECTRONICS AND THAT THERE WERE NO INJURIES AS A RESULT OF THE ISSUE. THE CUSTOMER ALSO STATED THAT THEY WOULD RETURN THE ORIGINAL PRODUCT. HOWEVER, AS OF THE DATE OF THIS REPORT THE PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. THOUGH THE ORIGINAL PRODUCT HAS NOT BEEN EVALUATED, 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 MFR 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOUSING FOR THEIR PUMP IN STYLE TRANSFORMER WAS FALLING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273923 PUMP IN STYLE HGX MEDELA, INC. 57062/9207010 REV M/ 1212

    Patients

    Seq Age Sex Outcome Treatment
    1