BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3063614 · Received April 12, 2013

    Report

    Report Number
    1419937-2013-00207
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE TRANSFORMER HOSING CRACKED AT THE TOP AND IT IS MISSING A SCREW. THE CUSTOMER STATED THAT SHE DID NOT SEE ANY SPARKING, SMOKING, FIRE OR MELTING. THE CUSTOMER ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. THE CUSTOMER HAS SENT THE DAMAGED TRANSFORMER BACK TO MEDELA, BUT AS OF THIS FILING IT HAS NOT BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER TRANSFORMER HOUSING FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157071 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 50736/9207010 UNK/REV. L

    Patients

    Seq Age Sex Outcome Treatment
    1