BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYA JOY

    MDR report key: 15565992 · Received October 7, 2022

    Report

    Report Number
    3009974348-2022-00357
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 13, 2022
    Manufacturer
    AMEDA., INC.
    Product Code
    HGX
    PMA / PMN Number
    K172989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NEGATIVE CONTACT SPRING IN BATTERY COMPARTMENT IS DAMAGED. EVIDENCE SUPPORTS THAT THE CONTACT SPRING WAS MOST LIKELY DAMAGED LOADING BATTERIES INTO THE BATTERY COMPARTMENT. TOP LEVEL NEGATIVE CONTACT SPRING POSSIBLY MADE CONTACT WITH LOWER LEVEL POSITIVE CONTACT PLATE AND BATTERY WHILE LOADING TOP BATTERY INTO BATTERY COMPARTMENT. FOUR AA (1.5 VOLTS MAX EACH) BATTERIES REQUIRED TO OPERATED THE MYA JOY PUMP HAS SIX VOLTS TOTAL LOAD, WAS UNABLE TO RECREATE CONDITION THAT RESULTED IN THE ALLEGED SPARK EVENT. RETURNED PUMP FUNCTIONS WITH AMEDA LAB AC ADAPTER AND BATTERIES.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2022 TO REPORT AN EVENT WHICH OCCURRED THAT MORNING AS SHE WAS INSTALLING AA BATTERIES INTO THE BATTERY COMPARTMENT OF HER AMEDA MYA JOY BREAST PUMP. SHE REPORTS ATTEMPTING TO PLACE THE SECOND BATTERY, WHICH SHE STATES WAS VERY DIFFICULT TO MANEUVER ALONGSIDE THE FIRST BATTERY, WHEN SPARKS WERE EMITTED MOMENTARILY FROM THE METAL BRACKET WHERE THE TOP SPRING IS LOCATED. MOM STATES SEEING A LIGHT WISP OF SMOKE AND DETECTED A BURNING ODOR. CUSTOMER DENIES ANY HARM TO HERSELF OR HER BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2896866 MYA JOY ELECTRIC BREAST PUMP HGX AMEDA., INC. LD-306 0920

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female