BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP INSTYLE (ITME #UNK)

    MDR report key: 4771425 · Received May 13, 2015

    Report

    Report Number
    1419937-2015-00141
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 8, 2015
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 TO BE RETURNED FOR EVAL. THE DEFECTIVE POWER ADAPTER HAS NOT BEEN RECEIVED AT MEDELA AS OF 05/08/2015. 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. CUSTOMER FOLLOW UP WAS NOT SUCCESSFUL. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. 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 TRANSFORMERS DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED MEDELA CUSTOMER SERVICE AND STATED HER PUMP IN STYLE TRANSFORMER HOUSING HAD CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314676 PUMP INSTYLE (ITME #UNK) HGX MEDELA, INC. 57XXXX/9207010 REV M UNK LOT

    Patients

    Seq Age Sex Outcome Treatment
    1