BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 3843571 · Received March 25, 2014

    Report

    Report Number
    1419937-2014-00295
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    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

    THE CUSTOMER'S REPORT OF A SPARK COMING FROM THE HOUSING OF HER POWER ADAPTER IS A SAFETY ISSUE. IN F/U WITH THE CUSTOMER, THE CUSTOMER STATED THAT THERE WERE NO INJURIES THAT RESULTED AND THAT SHE DISCARDED THE POWER ADAPTER. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN SHE WENT TO UNPLUG HER PUMP IN STYLE POWER ADAPTER, A BLUE SPARK CAME FROM THE TRANSFORMER HOUSING AND THE POWER ADAPTER WAS HOT TO THE TOUCH WHEN SHE WENT TO REMOVE IT FROM THE WALL OUTLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174121 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. UNK/9207010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1