BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 1943550 · Received December 3, 2010

    Report

    Report Number
    1419937-2010-00086
    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
    NY, 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), 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 APPROX 51 CM FROM THE STAIN RELIEF, MELTED OUTER INSULATION AND SIGNS OF EXCESSIVE HEAT, ALTHOUGH THE ODOR OF SMOKE COULD NOT BE DETECTED. THE TRANSFORMER WAS PLUGGED IN 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 61.4 OHMS WHICH IS NORMAL FOR THE TRANSFORMER AND INDICATES THAT THE INTERNAL THERMAL FUSE DID NOT BLOW. THE RESISTANCE ACROSS THE DC MEASURED 0.5 OHMS WHICH INDICATES A SHORT IN THE CORD. THE OUTER INSULATION WAS PEELED BACK AT THE BREACH APPROX 51 CM 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 THE CORD ON THE POWER ADAPTER WAS FRAYED AND MELTED AND STOPPED WORKING. SHE INDICATED THAT SHE DID NOT SEE A FIRE OR A SPARK, BUT DID SMELL BURNING PLASTIC. SHE ALSO INDICATED THAT SHE CUSTOMARILY WRAPPED THE CORD AROUND THE TRANSFORMER HOUSING.

    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