BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3072605 · Received April 19, 2013

    Report

    Report Number
    1419937-2013-00227
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. IN FOLLOW UP WITH THE CUSTOMER, SHE STATED THAT THE SCREWS FOR THE POWER SUPPLY CAME OUT, IT FELL APART, AND IT WAS BROKEN ON THE TOP OF THE HOUSING. THE CUSTOMER DID NOT WITNESS SMOKE, FIRE OR SPARKING AND STATED NO INJURIES WERE SUSTAINED. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THE CUSTOMER INDICATED THE SCREWS HAD COME OUT OF THE HOUSING AND IT FELL APART WHICH IS A SAFETY RISK. 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. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER BREAST PUMP CAME APART AFTER SHE UNPLUGGED IT FROM THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171099 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/9207010 REV L 2011

    Patients

    Seq Age Sex Outcome Treatment
    1