BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINESSE

    MDR report key: 10693254 · Received October 16, 2020

    Report

    Report Number
    3009974348-2020-00353
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 18, 2020
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    UDI-DI
    00810725023563
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED AC ADAPTER, P/N 4100103, MODEL DYS612-090130W-1 LOT 2819 HAS VISIBLE DAMAGE TO PRONGS (BENT UPWARD) AND ABOVE PRONG LOCATION 120V HOUSING, WHICH IS MISSING A SIGNIFICANT SECTION. FAINT ODOR OF AN ELECTRONIC COMPONENT FAILURE/THERMAL EVENT NOTICED. RETURNED AC ADAPTER, P/N 4100103, MODEL DYS612-090130W-1 LOT 2819 HOUSING WAS THEN OPENED FOR INTERNAL INVESTIGATION. REMOVED AC ADAPTER PCB TO INSPECT BOTH SIDES OF PCB WHERE DAMAGED PRONG IS CONNECTED/LOCATED. MINOR CHARRING IS EVIDENT AROUND DAMAGED PRONG/PCB CONNECTION LOCATION WHERE THERMAL EVENT OCCURRED. ENGINEERING CONCLUSION EVIDENCE DOES NOT SUPPORT AN EXPLOSIVE EVENT. DAMAGE TO THE PRONGS AND THEIR CONNECTION TO THE PCB INDICATES THAT THE AC ADAPTER MOST LIKELY SUSTAINED DAMAGE PRIOR TO THE "SPARK" EVENT. UNABLE TO DETERMINE THE FAULT OF AC ADAPTER FAILURE/DAMAGE. TESTING OF RETURNED FINESSE PUMP WAS WAIVED DUE TO COMMUNICATION LOG INDICATING THE PUMP STILL FUNCTIONS. PRELIMINARY INSPECTION OF RETURNED FINESSE P/N #4100018, S/N# (B)(4) /SW MEETS SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2020 TO REPORT AN EVENT THAT OCCURRED RECENTLY WHEN USING THE FINESSE PUMP WITH THE AMEDA AC ADAPTER. CUSTOMER HAS BEEN PUMPING FOR 5 MONTHS UP TO 4 TIMES/DAY. SHE INITIALLY REPORTS HEARING A "TICKING" SOUND COMING FROM THE AC ADAPTER. UPON SUBSEQUENT USE, SHE SAID THE AC ADAPTER FELT WARM TO THE TOUCH. FOLLOWING A FEW MORE USES, SHE SAID THE AC ADAPTER "SPARKED AND SEEMED TO FALL APART". SHE SAYS THE PUMP WILL STILL WORK, BUT SHE IS VERY CONCERNED. CUSTOMER WAS INSTRUCTED NOT TO USE THIS PUMP ANY LONGER. A REPLACEMENT FINESSE AND AC ADAPTER WAS SHIPPED OVERNIGHT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159033 FINESSE ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082 2819 00810725023563

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR