BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYA JOY

    MDR report key: 15428059 · Received September 15, 2022

    Report

    Report Number
    3009974348-2022-00356
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 19, 2022
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K172989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED MYA JOY AC ADAPTER WAS NOT TESTED CITING SAFETY CONCERNS. DAMAGE TO THE 120-VOLT TRANSFORMER HOUSING, PRONGS AND THEIR CONNECTION TO THE PCB INDICATES THAT THE RETURNED AC ADAPTER MOST LIKELY SUSTAINED DAMAGE PRIOR TO SPARK EVENT. AMEDA WAS UNABLE TO DETERMINE THE FAULT OF THE 120-VOLT TRANSFORMER HOUSING AND MISSING PRONG DAMAGE.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2022 TO REPORT SPARKING FROM THE MYA JOY POWER ADAPTER AS SHE PLUGGED IT INTO AN OUTLET AT WORK ON (B)(6) 2022. SHE IMMEDIATELY PULLED OUT THE ADAPTER FROM THE OUTLET BY GRASPING THE BLACK PLASTIC HOUSING WHICH THEN BROKE APART. ONE OF THE TWO PRONGS FELL OUT. CUSTOMER DENIED INJURY TO HERSELF. CUSTOMER WAS OVERNIGHT SHIPPED A REPLACEMENT MYA JOY POWER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271016 MYA JOY ELECTRIC BREAST PUMP HGX AMEDA, INC. LD-306 0920

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female