BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP

    MDR report key: 3960520 · Received June 24, 2014

    Report

    Report Number
    1419937-2014-00507
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. THE CUSTOMER REPORTED A BREACH IN THE TRANSFORMER HOUSING. SHE DID NOT REPORT OF ANY FIRE, SPARK, OR INJURY. 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. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER HOUSING OF HER PUMP IN STYLE BREAST PUMP HAD FALLEN APART EXPOSING THE UNDERLYING ELECTRONICS WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368487 PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP HGX MEDELA, INC. 9207010/57038 2313/REV N

    Patients

    Seq Age Sex Outcome Treatment
    1