BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 1963355 · Received December 17, 2010

    Report

    Report Number
    1419937-2010-00092
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 WITH THE ORIGINAL POWER CORD SHE DID NOT SEE A FIRE OR SPARK, BUT THAT THERE WAS MELTING AT THE POINT WHERE THE CORD MEETS THE TRANSFORMER AND SHE CONFIRMED THAT "WIRE SHOT OUT THE BACK OF MELTED PLASTIC." THE CUSTOMER INDICATED THAT SHE WOULD RETURN THE ORIGINAL POWER CORD, BUT IT HAS NOT YET BEEN RECEIVED. AS THE ORIGINAL PRODUCT IS NOT AVAILABLE FOR EVAL/ANALYSIS, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. SHOULD THE PRODUCT BECOME AVAILABLE, AN EVAL WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH SUBMITTED AT THAT TIME IF APPLICABLE. (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, THE POWER CORD SPARKED AND A WIRE SHOT OUT OF THE BACK OF THE TRANSFORMER.

    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