BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2060850 · Received March 11, 2011

    Report

    Report Number
    1419937-2011-00023
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. THE CUSTOMER INDICATED IN HER INITIAL REPORT THAT SHE HAD DISPOSED OF THE BAD TRANSFORMER. AS THE ORIGINAL PRODUCT IS NOT AVAILABLE FOR EVALUATION/ANALYSIS, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE. HOWEVER, SPARKING IS INDICATIVE OF AT LEAST ONE SHORT IN THE DC CORD, WHICH DOES NOT POSE AN ELECTROCUTION RISK SINCE IT IS ON THE DC SIDE OF THE TRANSFORMER; HOWEVER, SPARKING POSES A RISK SHOULD IT COME IN CONTACT WITH A COMBUSTIBLE MATERIAL. THEREFORE, THE DECISION WAS MADE TO SUBMIT A MEDWATCH. CAPA (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

    CUSTOMER REPORTED, HER POWER CORD WAS NO LONGER WORKING, AS THE WIRING HAD BEEN EXPOSED AND THE PROTECTIVE COVER WAS TORN. CUSTOMER INDICATED THE UNIT BECOMES VERY HOT IF PLUGGED IN AND ACTUALLY SPARKED ON ONE OCCASION. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1