BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3193169 · Received June 25, 2013

    Report

    Report Number
    1419937-2013-00328
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER SHE STATED SHE NOTICED THE CASING WAS BEGINNING TO SPLIT WHEN UNPLUGGING IT FROM THE WALL SHORTLY BEFORE I CONTACTED MEDELA FOR A REPLACEMENT. SHE ALSO INDICATED THAT SHE DID NOT WITNESS AND SPARKING, FIRE, OR FLAME AND THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. A PRODUCT EVAL REVEALED THAT THE TRANSFORMER HOUSING WAS BROKEN, EXPOSING THE INNER ELECTRONICS, WHICH IS A SAFETY RISK, SEE PAGE THREE FOR DETAILS. 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 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. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.79 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORE IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 55.08 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER TRANSFORMER HAD CRACKS IN IT. WHEN THE TRANSFORMER WAS REC'D BY MEDELA ON (B)(6) 2013, IT WAS BREACHED, EXPOSING THE INNER CIRCUITRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289007 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC 57036/9207010 REV L - 2011

    Patients

    Seq Age Sex Outcome Treatment
    1