BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK

    MDR report key: 6105755 · Received November 16, 2016

    Report

    Report Number
    1419937-2016-00294
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. 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). 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER HOUSING OF HER PUMP IN STYLE ADVANCED BREAST PUMP BROKE OPEN EXPOSING THE INNER ELECTRONICS, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758437 PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK PUMP, BREAST, POWERED HGX MEDELA, INC 9207010/57062 REV N/1313

    Patients

    Seq Age Sex Outcome Treatment
    1