BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4651264 · Received March 26, 2015

    Report

    Report Number
    3009974348-2015-00064
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    February 27, 2015
    Report Date
    February 27, 2015
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SHIPPED A REPLACEMENT PURELY YOURS BREAST PUMP AND AC ADAPTER ON (B)(4) 2015. THE USED PURELY YOURS BREAST PUMP AND AC ADAPTER WAS RETURNED TO AMEDA ON 03/11/2015 AND IS CURRENTLY BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED PRODUCT INDICATED THAT THE SMOKE OBSERVED BY THE CUSTOMER COULD BE FROM THE COATING OF THE BATTERY CONTACTS INSIDE OF THE PURELY YOURS BREAST PUMP. A VISUAL INSPECTION OF RESERVED PURELY YOURS BREAST PUMPS INDICATED THAT THE COATING OF THE BATTERY CONTACTS WAS VISUALLY INCONSISTENT INDICATING THE MANUFACTURING PROCESS WAS INCONSISTENT. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC ON (B)(6) 2015 TO REPORT GRAY SMOKE EMITTED FROM THE LEFT SIDE OF THE MOTOR BASE NEAR THE AC ADAPTER PORT WHILE USING THE PURELY YOURS BREAST PUMP PLUGGED INTO AN ELECTRICAL OUTLET AT HOME. CUSTOMER REPORTED LEFT SIDE OF BREAST PUMP BECAME WARM TO TOUCH. CUSTOMER DENIED INJURY OR BURN AND DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201946 PURELY YOURS ELECTROC BREAST PUMP, 884.5160 HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1