BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 3193155 · Received June 25, 2013

    Report

    Report Number
    1419937-2013-00333
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDELA,INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVAL. THE DEFECTIVE POWER CORD HAS NOT BEEN REC'D AT MEDELA AS OF (B)(4) 2013. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. 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 MFR 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 TRANSFORMER DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TRANSFORMER HOUSING BROKE INTO PIECES MAKING IT UNUSABLE. DAMAGED TRANSFORMER HOUSING - BREACH PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287074 PUMP IN STYLE (ITEM # UNK) HGX MEDELA,INC. 57XXX/9207010 REV L

    Patients

    Seq Age Sex Outcome Treatment
    1