BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 3843536 · Received March 25, 2014

    Report

    Report Number
    1419937-2014-00291
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, THE CUSTOMER REPORTED THAT SHE COULD SEE THE INNER ELECTRONICS OF HER TRANSFORMER, WHICH IS A SAFETY RISK. SHE ALSO STATED THAT SHE WOULD RETURN THE ORIGINAL POWER ADAPTER AS SOON AS SHE RECEIVES HER REPLACEMENT. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED RESULTING IN NEW, CHANGED, OR CORRECT INFO, A F/U 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 STAKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING MONITORED FOR EFFECTIVENESS OF THE ABOVE MENTIONED CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOUSING FOR THEIR PUMP IN STYLE POWER ADAPTER WAS CRACKED OPEN, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174088 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 57062/9207010 REV M/ 5112

    Patients

    Seq Age Sex Outcome Treatment
    1