BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 3181630 · Received June 14, 2013

    Report

    Report Number
    1419937-2013-00318
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE SMELLED A BURNING ODOR COMING FROM THE BREACHED TRANSFORMER, BUT NO SIGNS OF SMOKE, FIRE OR MELTING. NOR WAS THERE A REPORT OF AN INJURY. THE CUSTOMER ALSO STATED THAT SHE WOULD BE SENDING BACK THE DEFECTIVE PRODUCT, BUT AS OF THE DATE OF THIS REPORT THE PRODUCT HAS NOT BEEN RECEIVED BY MEDELA. SHOULD THE PRODUCT BE RECEIVED AND EVALUATED AND ANY NEW INFO BE OBTAINED, A FOLLOW-UP REPORT WILL BE FILED. THIS ISSUE WITH THE DAMAGED TRANSFORMER USING 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 MANUFACTURERS 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 ON THEIR PUMP IN STYLE TRANSFORMER CRACKED IN HALF EXPOSING UNDERLYING ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271013 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 57062/9207010 1212/REV M

    Patients

    Seq Age Sex Outcome Treatment
    1