BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 3834537 · Received March 19, 2014

    Report

    Report Number
    1419937-2014-00283
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME; THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. 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 (B)(4) 2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THERE WAS SPARKING FROM THE EXPOSED WIRES ON THE CORD OF HER PUMP IN STYLE TRANSFORMER. NOTE: DURING CONVERSATION WITH THE CUSTOMER SERVICE REPRESENTATIVE, IT WAS IDENTIFIED THAT THE PUMP WAS BEING USED SECOND HAND. CUSTOMER SERVICE ALERTED THE CUSTOMER TO THE ISSUES WITH USING A SECOND HAND PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162281 PUMP IN STYLE HGX MEDELA, INC. 57XX/9207010 PRIOR TO REV L-13L

    Patients

    Seq Age Sex Outcome Treatment
    1