BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2844294 · Received November 8, 2012

    Report

    Report Number
    1419937-2012-00707
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 13, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACE POWER SUPPLY WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. ATTEMPTS TO RETRIEVE THE PRODUCT AND TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL, INCLUDING A FINAL ATTEMPT BY LETTER. 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 ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER TRANSFORMER WAS SPARKING FROM EXPOSED WIRES ON THE CORD. SHE DID NOT WITNESS FLAMES OR SMOKE, NO INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 17E/PRIOR TO REV L

    Patients

    Seq Age Sex Outcome Treatment
    1