BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNSA STARTER BP EN ES USA

    MDR report key: 8960598 · Received September 4, 2019

    Report

    Report Number
    1419937-2019-00117
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 21, 2019
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 08/23/2019, THE CUSTOMER INDICATED THAT WHEN SHE WENT TO UNPLUG THE POWER SUPPLY FROM THE WALL, THE POWER SUPPLY STARTED ON FIRE AND BROKE INTO THREE PIECES. THE CUSTOMER ALSO INDICATED THAT THE BURN ON HER FIGURE WAS NOT BAD. THE CUSTOMER WAS CONTACTED AGAIN ON 08/28/2019 AND SHE INDICATED THAT SHE RECEIVED THE REPLACEMENT POWER SUPPLY AND WOULD BE RETURNING THE OLD ONE. THIS ISSUE WITH A DAMAGED REV M POWER SUPPLY FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THEY WERE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE WAS CAUSING THE PLASTIC HOUSING TO FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER TO SHIP THE POWER SUPPLY TO MEDELA WAS 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 WAS MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH WAS ALSO INCREASED TO FURTHER PROTECT THE POWER SUPPLY DURING SHIPPING. SINCE THEN, AS A PART OF ROUTINE CONTINUOUS IMPROVEMENT ACTIVITIES, A REV P POWER SUPPLY HAS BEEN DISTRIBUTED TO MARKET, MANUFACTURED UNDER A REVISED DESIGN AND BY A DIFFERENT MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP "EXPLODED INTO FLAMES" AND FELL APART INTO THREE PIECES. THE CUSTOMER ALSO ALLEGED THAT SHE BURNT HER FINGER, THOUGH MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755125 PNSA STARTER BP EN ES USA PUMP, BREAST, POWERED HGX MEDELA LLC 101035077 9207010/REV M 3612

    Patients

    Seq Age Sex Outcome Treatment
    1