BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10516872 · Received September 10, 2020

    Report

    Report Number
    1419937-2020-00099
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 24, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K191653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A NEW POWER ADAPTER AND RETURN OF THEIR ORIGINAL POWER ADAPTER 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 (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE USB CONNECTOR ON THE POWER ADAPTER FOR HER FREESTYLE FLEX BREAST PUMP MELTED. THE CUSTOMER STATED SHE WAS USING THE CORRECT POWER ADAPTER AND IT WAS PLUGGED INTO A WALL OUTLET, BUT NOT INTO THE PUMP, WHEN THE MELTING OCCURRED. SHE ALSO INDICATED THAT THE USB CONNECTOR ON THE POWER ADAPTER CORD WAS HOT, BUT THE PUMP HOUSING WHERE THE USB CONNECTOR WAS INSERTED WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983653 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 167398

    Patients

    Seq Age Sex Outcome Treatment
    1