BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP TO TOTE

    MDR report key: 3243138 · Received July 18, 2013

    Report

    Report Number
    1419937-2013-00361
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH CUSTOMER, SHE INDICATED THAT THE SCREW HAD FALLEN OUT OF HER TRANSFORMER EXPOSING UNDERLYING ELECTRONICS. SHE DID NOT REPORT OF ANY SPARKING, FIRE, FLAME OR INJURY. THE CUSTOMER STATED THAT SHE WILL RETURN THE ORIGINAL DEFECTIVE PRODUCT TO MEDELA, BUT AS OF THE DATE OF THIS REPORT MEDELA HAS NOT REC'D THAT PRODUCT. SHOULD THE PRODUCT BE REC'D AND EVALUATED RESULTING IN ANY NEW INFO, A FOLLOW-UP REPORT WILL BE FILED. 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 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 TRANSFORMER 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 BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOUSING TO PUMP IN STYLE TRANSFORMER HAS COME APART AND THE SCREWS HAVE FALLEN OUT EXPOSING UNDERLYING ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335348 PUMP IN STYLE ADVANCED BREAST PUMP TO TOTE HGX MEDELA, INC. 57063/9207010 REV L/0912

    Patients

    Seq Age Sex Outcome Treatment
    1