BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2092951 · Received April 19, 2011

    Report

    Report Number
    1419937-2011-00085
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE SAW SMOKE AND A SMALL FLAME ("YELLOW, TINY") ALONG THE LENGTH OF THE CORD IN THE MIDDLE AND SMELLED BURNING ELECTRONICS. SHE INDICATED THAT THERE WAS NO BREACH IN THE TRANSFORMER HOUSING AND NO EXPOSED WIRES ON THE CORD. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. REFER TO PAGE 3, EVAL SUMMARY, FOR DETAILS OF THE ANALYSIS/EVAL PERFORMED ON THE POWER SUPPLY. IN SUMMARY, THE CORD WAS KINKED AND TWISTED AND THERE WAS EVIDENCE OF MELTING (IT CANNOT BE DETERMINED IF THE MELTING WAS INTERNAL OR EXTERNAL), THOUGH A SHORT WAS NOT OBSERVED AND THE FUSE WAS NOT BLOWN. A CONCLUSION AS TO THE CAUSE OF THE EVENT CANNOT BE DEFINITIVELY DRAWN. 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 (B)(6) 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 BREACHES. A VISUAL EXAMINATION OF THE CORD REVEALED TWISTING AND KINKING OF THE CORD, NO EXPOSED WIRES AND SIGNS OF MELTING AT APPROX 65CM FROM THE STRAIN RELIEF. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.6 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 382.1 OHMS, 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 63.6 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 THE POWER SUPPLY FOR HER PUMP CAUGHT ON FIRE ABOUT ONE MONTH AGO ("THERE WAS A SMALL FLAME"). THE CUSTOMER WAS ABLE TO QUICKLY UNPLUG THE POWER SUPPLY AND THERE WAS NOT A LOT OF DAMAGE DONE TO THE CORD. THE PUMP WORKS FINE WITH THE BATTERY PACK. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC. 57036

    Patients

    Seq Age Sex Outcome Treatment
    1