BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1943541 · Received December 3, 2010

    Report

    Report Number
    1419937-2010-00085
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SHIPPED TO THE CUSTOMER, WHICH THE CUSTOMER STATES IS WORKING WITHOUT ISSUE. EVALUATION SUMMARY: FOR DETAILS OF THE ANALYSIS/EVALUATION PERFORMED ON THE TRANSFORMER. IN SUMMARY, A BREACH IN THE OUTER INSULATION OF THE CORD WAS PRESENT AND COULD ALLOW A SHORT TO SPARK. THE BREACH IN THE INSULATION IS LIKELY THE RESULT OF THE MULTIPLE KINKS, TWISTS AND DEFORMATIONS EXAMINED IN THE CORD WHICH ARE INDICATIVE OF USER HANDLING. CAPA (B)(4), APPROVED ON (B)(6) 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 TRANSFORMER SHOWED NO SIGNS OF BURNING OR DEFORMATION ON THE PLASTIC HOUSING. THE SMELL OF SMOKE COULD NOT BE DETECTED ON THE TRANSFORMER. A KINK IN THE CORD AT THE END OF THE STRAIN RELIEF AND NUMEROUS ADDITIONAL KINKS, TWISTS AND DEFORMATIONS THROUGHOUT THE CORD, RELATED TO USER HANDLING, WERE ALSO OBSERVED, ALONG WITH A BREACH IN THE OUTER INSULATION WHICH APPEARS MELTED AND SHOWS SIGNS OF EXCESSIVE HEAT ALTHOUGH THE ODOR OF SMOKE AT THIS AREA COULD NOT BE DETECTED. THE TRANSFORMER WAS PLUGGED IN AND THE VOLTAGE WAS MEASURED AT 12.15V, WHICH IS WITHIN NORMAL RANGE AND INDICATES THAT THE TRANSFORMER IS WORKING PROPERLY. THE CORD WAS MANIPULATED AROUND THE BREACH IN THE INSULATION AND THE VOLTAGE READING FLUCTUATED SIGNIFICANTLY AND SPARKS AND SMOKE WERE VISIBLE. THE RESISTANCE ACROSS THE AC MEASURED 62.3 OHMS WHICH IS NORMAL FOR THE TRANSFORMER AND INDICATES THAT THE INTERNAL THERMAL FUSE DID NOT BLOW. THE RESISTANCE ACROSS THE DC MEASURED 0.6 OHMS WHICH INDICATES A SHORT IN THE CORD. THE OUTER INSULATION WAS PEELED BACK AT THE BREACH APPROX 20CM FROM THE STRAIN RELIEF AND A BREAK IN THE INNER INSULATION THAT SEPARATES THE POSITIVE AND NEGATIVE WIRES WAS OBSERVED. THIS COULD CONTRIBUTE TO A SHORT WHICH COULD INCREASE THE AMOUNT OF CURRENT RUNNING THROUGH BOTH THE TRANSFORMER AND THE CORD AND COULD RESULT IN THE TRANSFORMER AND CORD HEATING UP. THE BREACH IN THE OUTER INSULATION COULD ALLOW THE SHORT TO SPARK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SHE WAS PUMPING, THE SUCTION SUDDENLY STOPPED AFTER 15 MINUTES. SHE TURNED THE PUMP OFF AND BACK ON. WHEN SHE DID THIS, THE SUCTION RESUMED AND THE POWER ADAPTER CORD, WHICH WAS ON A TABLE, SPARKED AND SET A NAPKIN ON FIRE. THE FIRE WAS IMMEDIATELY PUT OUT. WHEN THE CUSTOMER REMOVED THE POWER ADAPTER FROM THE WALL OUTLET, SHE NOTICED THAT A SMALL PORTION OF THE CORD HAD MELTED. THE CUSTOMER INDICATED THAT SHE WOULD CUSTOMARILY "WRAP THE CORD AROUND HER PALM LOOSELY AND THAT THE CORD WAS TWISTED IN SOME SPOTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED NONE HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1