BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 1963359 · Received December 17, 2010

    Report

    Report Number
    1419937-2010-00090
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER CORD WAS SHIPPED TO THE CUSTOMER. IN FOLLOW UP DISCUSSIONS WITH THE CUSTOMER, SHE INDICATED THAT THE REPLACEMENT POWER CORD IS WORKING WITHOUT ISSUE. SHE ALSO INDICATED THAT SHE DID NOT SEE A FIRE OR SPARK, BUT THAT THE BACK OF THE TRANSFORMER HAD A PENCIL POINT SIZED HOLE BURNT THROUGH IT TO THE POINT WHERE YOU CAN SEE METAL. SHE STATED THAT THE TRANSFORMER GOT "SUPER HOT" BUT "I WAS NOT INJURED IN ANY WAY AT ALL." THE CUSTOMER INDICATED THAT SHE DISPOSED OF THE ORIGINAL POWER CORD. AS THE ORIGINAL PRODUCT IS NOT AVAILABLE FOR EVAL/ANALYSIS, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. (B)(4), APPROVED ON (B)(4) 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SHE WAS USING HER PUMP, SHE DETECTED A BURNING ODOR, THE PUMP STOPPED WORKING, AND WHEN SHE TOUCHED THE TRANSFORMER IT WAS "VERY HOT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1