BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINESSE

    MDR report key: 9868270 · Received March 23, 2020

    Report

    Report Number
    3009974348-2020-00349
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    February 23, 2020
    Report Date
    February 24, 2020
    Manufacturer
    AMEDA.COM
    Product Code
    HGX
    UDI-DI
    00810725023563
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION THAT THIS REPLACEMENT FINESSE PUMP (205190935/SW) SUDDENLY SHUT OFF WHEN ADJUSTING THE SUCTION DIAL PAST THE MEDIUM SETTING AND THAT THE FINESSE PUMP BASE THEN SHOCKED THE RIGHT PALM OF USER WHEN ATTEMPTING TO MOVE PUMP BASE TO A NEW OUTLET IS HIGHLY IMPLAUSIBLE. MATERIALS SUCH AS PLASTIC ARE BAD CONDUCTORS OF ELECTRICITY. THEY DO NOT ALLOW ELECTRICITY TO FLOW THROUGH THEM. THE ALLEGATION THAT THE AC ADAPTER, P/N 4100003, MODEL DYS612-090130W-1 LOT 3316 MADE A "SHOCK" SOUND WHEN MOVED TO A NEW OUTLET IS ALSO DUBITABLE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. 02/24/2020 TO REPORT EXPERIENCING AN ELECTRICAL SHOCK AFTER HER AMEDA FINESSE PUMP POWERED OFF DURING PUMPING. AFTER THE PUMP POWERED ITSELF OFF, CUSTOMER PLACED HER RIGHT PALM UNDER THE PUMP BASE TO MOVE IT AND EXPERIENCED AN ELECTRICAL SHOCK THAT FRIGHTENED HER. SHE DENIED PAIN, INJURY OR BURN IN THIS EVENT. CUSTOMER STOPPED USING THE PUMP THAT DAY AND PHONED AMEDA. CUSTOMER WAS SHIPPED A REPLACEMENT FINESSE PUMP BASE AND AC ADAPTER OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329921 FINESSE ELECTRIC BREAST PUMP HGX AMEDA.COM 4100018 00810725023563

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR