BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2060853 · Received March 11, 2011

    Report

    Report Number
    1419937-2011-00019
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN A FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE A FIRE, SMOKE OR SPARKING BUT THAT THERE WAS A HOLE IN THE TRANSFORMER HOUSING WITH A METAL PIECE POKING THROUGH. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. REFER TO EVALUATION SUMMARY FOR DETAILS OF THE ANALYSIS/EVALUATION PERFORMED ON THE POWER SUPPLY. IN SUMMARY, A BREACH IN THE INNER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT AND RESULTED IN A SHORT CIRCUIT WHICH CAUSED THE CORD TO HEAT UP AND BURN A HOLE IN THE TRANSFORMER, WHICH IS A SAFETY RISK. CAPA (B)(4), APPROVED ON 11/18/2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADDITIONAL FOLLOW UP ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS. EVALUATION SUMMARY - A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED A DEFORMATION ON THE TRANSFORMER HOUSING WITH A 1.4 MM DIAMETER HOLE WITH A METAL WIRE PROTRUDING 1.8MM FROM THE HOLE. A VISUAL EXAMINATION OF THE CORD REVEALED A KINK AT THE STRAIN RELIEF, NO EXPOSED WIRES, AND NO SIGNS OF FIRE OR BURNING. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.00 VDC, WHICH INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.4 OHMS, WHICH INDICATES THAT THERE IS 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 OPEN, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID BLOW. THE OUTER INSULATION WAS REMOVED AT THE STRAIN RELIEF TO EXPOSE A BREAK IN THE INNER INSULATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP SMELLED OF BURNT PLASTIC AND THAT A METAL PIECE IS SHOWING THROUGH THE TRANSFORMER HOUSING. SHE INDICATED THAT SHE HAS BEEN PLUGGING HER POWER ADAPTER INTO THE SAME SURGE PROTECTOR AND ELECTRICAL OUTLET FOR 3 1/2 MONTHS AND HAS NEVER NOTICED THAT THE CORD WAS HOT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1