BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3261835 · Received July 30, 2013

    Report

    Report Number
    1419937-2013-00384
    Event Type
    Malfunction
    Date Received
    July 30, 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
    LA, 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 THE POWER WAS NOT BREACHED WHILE IN HER POSSESSION. CUSTOMER DID NOT WITNESS SPARK, FIRE, OR SMOKE, AND DID NOT SUSTAIN ANY INJURIES. THE PRODUCT WAS RECEIVED ON (B)(4) 2013. THOUGH THE PRODUCT HAS BEEN RECEIVED, IT HAS NOT YET BEEN TESTED/ANALYZED BY QUALITY ENGINEERING. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. HOWEVER, THE PRODUCT WAS RECEIVED INTO MEDELA, INC BREACHED, WHICH IS A SAFETY RISK. THIS ISSUE WITH THE 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 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 PRO-CESS 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 SHE COULD HEAR A HUMMING NOISE COMING FROM THE POWER SUPPLY FOR BREAST PUMP. UPON RECEIPT OF THE PRODUCT, IT WAS FOUND TO BE BREACHED WITH INNER WIRING EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355837 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV M 1212

    Patients

    Seq Age Sex Outcome Treatment
    1