BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYA JOY PLUS

    MDR report key: 16308861 · Received February 6, 2023

    Report

    Report Number
    3009974348-2023-00359
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 11, 2023
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K203570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE POTENTIAL ROOT CAUSE OF THE DAMAGE ON THE MYA JOY PLUS PUMP POWER ADAPTER TYPE C PLUG MAY BE EXCESS "CONTACT RESISTANCE" MALFUNCTION/FAILURE DUE TO CONTAMINATION. BREAST MILK RESIDUE WAS FOUND ON THE BOTTOM OF THE PUMP BASE. THE MALFUNCTION/FAILURE DID NOT IMPACT OR DAMAGE THE RETURNED POWER ADAPTER BASE UNIT, RETURNED MYA JOY PLUS PUMP'S INTERNAL BATTERY, OR COMPONENTS ON THE MYA JOY PLUS CIRCUIT BOARD INSIDE THE PUMP BASE.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED AMEDA, INC. ON 01/11/2023 TO REPORT AN EVENT WHICH OCCURRED WITH HER AMEDA BREAST PUMP. SHE REPORTS PLUGGING THE MYA JOY PLUS INTO AN ELECTRICAL OUTLET IN HER KITCHEN TO CHARGE USING THE AMEDA USB CHARGER. SHE USED THE SAME ELECTRICAL OUTLET NEXT TO A BOTTLE WARMER, NOT IN USE. SHE WENT FOR A WALK AND WHEN SHE RETURNED IN 45 MINUTES, SHE SMELLED AN ODOR AS THOUGH PLASTIC WAS BURNING. CUSTOMER FOUND THE END OF THE USB AC ADAPTER PORT HAD MELTED WHERE IT CONNECTS TO THE PUMP BASE. MOM STATES THAT 1-2 DAYS PRIOR TO THIS EVENT, THE PUMP SCREEN READ ERROR WHEN SHE CHARGED THE PUMP AND THE CHARGER FELT WARM TO TOUCH. CUSTOMER WAS NOT HARMED IN THIS EVENT. A REPLACEMENT MYA JOY PLUS BREAST PUMP WITH USB AC ADAPTER WAS SHIPPED OVERNIGHT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495470 MYA JOY PLUS ELECTRIC BREAST PUMP HGX AMEDA, INC. MYA JOY PLUS 0920

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female