BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3042833 · Received April 4, 2013

    Report

    Report Number
    1419937-2013-00193
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. CONTACT WAS NOT MADE WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS RETURNED TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS RETURNED AND EVALUATED. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.84 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 SHORT 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 55.12 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THE EVALUATION CONFIRMED THE BREACH IN THE HOUSING WHICH IS A SAFETY RISK. 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 FORSEEABLE 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, RESULTING IN NEW, CHANGED OR CORRECT INFORMATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO CUSTOMER SERVICE TO REPORT THAT THE PUMP IN STYLE ADAPTER HOUSING COMPLETELY FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138018 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/9207010 REV L-1811

    Patients

    Seq Age Sex Outcome Treatment
    1