BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10648971 · Received October 8, 2020

    Report

    Report Number
    1419937-2020-00112
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 14, 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 ADVISED THE CUSTOMER DURING TROUBLE SHOOTING TO RESET THE PUMP AND LET IT CHARGE. ON 09/14/2020, THE CUSTOMER CONTACTED CUSTOMER SERVICE AND STATED THAT THE CHARGING PORT WHERE THE POWER CORD PLUGS INTO THE PUMP HAD MELTED AND THE DEVICE WILL NOT POWER ON. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF THEIR ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA (B)(4), THE LEGAL MANUFACTURER IN (B)(4).

    Description of Event or Problem · 1

    ON JUNE 11, 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE SPILLED A LITTLE MILK ON THE DISPLAY OF HER FREESTYLE FLEX BREAST PUMP AND NOW IT WILL NOT POWER ON WITH THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118363 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1