BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 2864621 · Received December 6, 2012

    Report

    Report Number
    1419937-2012-00781
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SOURCE WAS SENT TO THE CUSTOMER. ATTEMPTS TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL. THE PRODUCT INVOLVED IN THE COMPLAINT HAS NOT BEEN RECEIVED FOR TESTING/ANALYSIS. HOWEVER, THE CUSTOMER REPORTED THAT THE SPARKING WAS FROM THE EXPOSED WIRE ON THE CORD. THE CUSTOMER ALSO STATED THAT THERE WERE NO INJURIES FROM THIS ISSUE. 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 ONGOING. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECT INFORMATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE SAW SPARKS COMING FROM THE COPPER WIRES ON HER TRANSFORMER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/9207010 I2F

    Patients

    Seq Age Sex Outcome Treatment
    1