BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2142160 · Received May 26, 2011

    Report

    Report Number
    1419937-2011-00116
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT A FLAME CAME OUT OF THE TOP OF THE TRANSFORMER JUST AS THE PRONGS ENTERED THE WALL OUTLET, BUT THERE IS NO BREACH IN NEITHER THE TRANSFORMER HOUSING NOR THE CORD. SHE ALSO INDICATED THAT SHE RECEIVED A "LITTLE SHOCK BUT IT DIDN'T HURT." EVAL SUMMARY: IN SUMMARY, BECAUSE THERE WAS NO EVIDENCE OF NEITHER DAMAGE TO THE DC OUTPUT CORD NOR A SHORT, IT CAN BE REASONABLY DETERMINED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE AC INPUT SOURCE. HOWEVER, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED NO DEFORMATION ON THE TRANSFORMER HOUSING AND NO HOLES OR OPENINGS. DISCOLORATION ON THE TOP OF THE TRANSFORMER HOUSING WAS NOTED, BUT THERE WAS NO EVIDENCE OF BURNING OR CHARRING OR DEFORMATION OF THE PLASTIC. A VISUAL EXAMINATION OF THE CORD REVEALED NO DAMAGE. THE POWER SUPPLY WAS PLUGGED IN THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.8 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AS 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 AT 64.5 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 WHEN HIS WIFE TRIED TO USE HER BREAST PUMP, SMOKE AND FLAME CAME OUT OF THE POWER SUPPLY. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1