BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 3941895 · Received June 3, 2014

    Report

    Report Number
    1419937-2014-00470
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. 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. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSION CAN BE MADE AS TOT HE CAUSE OF THE EVENT. ATTEMPTS TO RETRIEVE THE PRODUCT AND TO GET ADDITIONAL COMPLAINT INFORMATION ON GOING. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. THE ISSUE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THAT HER TRANSFORMER HOUSING HAS CRACKED ANS SHE CAN SEE INSIDE. SHE DIDN'T SEE ANY SPARKING OR ANYTHING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323388 BP ADVANCED PERSONAL DOUBLE HGX MEDELA INC. 57065/9207010 REV N -1413

    Patients

    Seq Age Sex Outcome Treatment
    1