BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 3770471 · Received February 18, 2014

    Report

    Report Number
    1419937-2014-00189
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN THE FOLLOW UP WITH THE CUSTOMER SHE STATED THAT THE PLASTIC AROUND THE SCREWS ON THE TRANSFORMER HOUSING CRACKED AND THEN TWO PIECES SEPARATED AND FELL APART SO YOU CAN SEE THE UNDERLYING WIRES, WHICH IS A SAFETY RISK. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED IN RESULTING IN NEW, CHANGED OR CORRECT INFORMATION, A FOLLOW UP WILL BE FILED AT THAT TIME. THIS ISSUE WITH A 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 MANUFACTURER 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. THIS CORRECTIVE ACTION APPLIES TO TRANSFORMERS WITH A DATE CODE GREATER THAN OR EQUAL TO (B)(4). COMPLAINT DATA TRENDING WILL CONTINUE TO BE MONITORED BY MEDELA QUALITY MANAGEMENT FOR INVESTIGATION/CAPA CONSIDERATION. POSSIBLE RESOLUTIONS PROVIDED TO CUSTOMER: REPLACEMENT PRODUCT OR ONLINE ORDERING INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HER TRANSFORMER FOR HER PUMP IN STYLE JUST KIND OF FELL APART WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103477 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 57062/9207010 REV L - 1811

    Patients

    Seq Age Sex Outcome Treatment
    1