BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2982744 · Received February 25, 2013

    Report

    Report Number
    1419937-2013-00121
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. CONTACT WAS NOT MADE WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. HOWEVER, THE CUSTOMER STATED THE POWER CORD BURNT APART, WHICH COULD BE A SAFETY RISK. THIS PRODUCT WAS RELEASED AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER BREAST PUMP GOT HOT AND "BURNED APART."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79179 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063 / 9207010 REV L

    Patients

    Seq Age Sex Outcome Treatment
    1