BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10547975 · Received September 17, 2020

    Report

    Report Number
    1419937-2020-00101
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 24, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE HAD THE CUSTOMER RESET HER PUMP, REQUESTED SHE CHARGE IT FOR 2 HOURS, AND ASKED HER TO CALL BACK IF SHE HAD FURTHER ISSUES. ON (B)(6) 2020, THE CUSTOMER CALLED IN AND ALLEGED THAT HER FREESTYLE FLEX HAD A MELTED CHARGING PORT AND POWER CORD. CUSTOMER SERVICE SENT THE CUSTOMER A REPLACEMENT DEVICE AND RETURN OF HER ORIGINAL DEVICE WAS REQUESTED FOR TESTING/EVALUATION. IN FURTHER FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2020, THE CUSTOMER INDICATED THAT THE DEVICE AND POWER ADAPTOR HAD BEEN PLUGGED INTO A WALL OUTLET WITH A NON-MEDELA CHARGING WHEN SHE NOTICED AFTER AN HOUR AND A HALF OF CHARGING THAT THE DEVICE'S CHARGING PORT AND THE NON-MEDELA POWER CORD WERE MELTED. SHE ADDITIONALLY INDICATED THAT SHE HAD PURCHASED THE NON-MEDELA CHARGING CORD BECAUSE HER PUMP HAD NOT BEEN CHARGING WITH THE CORD THAT CAME WITH THE PUMP, BUT SHE KNEW THE POWER ADAPTOR WAS WORKING SINCE SHE HAD TESTED IT WITH HER PHONE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA AG, THE LEGAL MANUFACTURER IN (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE FLEX BREAST PUMP WAS NOT CHARGING PAST SIXTY THREE PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016036 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 162128 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1