BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10406917 · Received August 14, 2020

    Report

    Report Number
    1419937-2020-00085
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    April 13, 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 CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING INSPECTING THE POWER SUPPLY AND PUMP FOR DAMAGE; CHECKING THE POWER SUPPLY FOR SECURE FIT TO PUMP AND WALL OUTLET; AND RESETTING THE PUMP. AFTER TROUBLESHOOTING, THE CUSTOMER INDICATED THAT THE PUMP DID STILL NOT POWER ON. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. THE PUMP WAS EVALUATED ON (B)(6) 2020 AND IT WAS IDENTIFIED DURING THE EVALUATION THAT THERE WAS MELTING OF THE POWER CORD AND PUMP. 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 WOULD NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870222 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 161567 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1