BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 3061314 · Received April 10, 2013

    Report

    Report Number
    1419937-2013-00203
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 17, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER CORD WAS SENT TO THE CUSTOMER. THE CUSTOMER CALLED MEDELA CUSTOMER SERVICE AND STATED THE TRANSFORMER HOUSING IS BROKEN AND THE WIRES ARE EXPOSED. THE POWER CORD WAS REPLACED AND REQUESTED THE DEFECTIVE POWER CORD TO BE RETURNED FOR EVAL. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. IN THE FOLLOW-UP WITH THE CUSTOMER, SHE STATED THERE WAS A BREACH AT THE TRANSFORMER HOUSING AND IT FELL APART. SHE HAD USED THE PUMP FOR 4 MONTHS, ABOUT 2 TO 3 TIMES A DAY. THE POWER CORD IS PLUGGED/UNPLUGGED ABOUT 3 TIMES A DAY. SHE INDICATED SHE DID NOT WITNESS ANY SPARKING, FIRE, OR FLAME, AND THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THIS ISSUE. 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 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

    CUSTOMER REPORTED THAT THE TRANSFORMER HOUSING IS BROKEN AND THE WIRES ARE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148671 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 9207010/57062 REV M 1212

    Patients

    Seq Age Sex Outcome Treatment
    1