BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3001956 · Received March 11, 2013

    Report

    Report Number
    1419937-2013-00141
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. ATTEMPTS TO GET THE PRODUCT BACK WERE UNSUCCESSFUL. AS OF THIS DATE, THE PRODUCT HAS NOT BEEN RECEIVED. IN FOLLOW UP WITH THE CUSTOMER SHE STATED THAT SHE HEARD POP AND LOOK DOWN AND SHE SAW SPARK, WHICH IS SAFETY RISK. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE WIRES ON HER ADAPTOR ARE EXPOSED AND SHE SAW A SPARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101730 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 16F

    Patients

    Seq Age Sex Outcome Treatment
    1