BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP ADVANCED

    MDR report key: 15041913 · Received July 18, 2022

    Report

    Report Number
    3010359222-2022-00002
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    June 23, 2022
    Report Date
    November 2, 2022
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGX
    PMA / PMN Number
    K203383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS MAKING EFFORTS TO RETRIEVE THE DEVICE FROM THE CONSUMER. WE MEET ALL OF THE RELEVANT SAFETY STANDARDS FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 0

    PHILIPS IS MAKING EFFORTS TO RETREIVE THE DEVICE FROM THE CONSUMER. WE MEET ALL OF THE RELEVANT SAFETY STANDARDS FOR THIS PRODUCT. FOLLOW UP REPORT #1: DESPITE THE EFFORTS TO OBTAIN THE DEVICE FROM THE CUSTOMER, THE DEVICE WAS NOT RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE PERFORMED, THEREFORE NO ROOT CAUSE WAS ABLE TO BE DETERMINED. THIS IS THE FIRST TIME THAT PHILIPS HAS SEEN A COMPLAINT OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER'S BREAST PUMP DEVICE WAS PLUGGED IN AND CHARGING WHEN THE CUSTOMER NOTICED BLACK SMOKE AND THE END OF THE POWERCORD TURNED BLACK. NO INJURIES REPORTED BY THE CUSTOMER. THE CONSUMER STATED THEY WERE TO BE CONTACTING AN ELECTRICIAN TO DETERMINE THE SOURCE OF THE ISSUE.

    Description of Event or Problem · 0

    CUSTOMER''S BREAST PUMP DEVICE WAS PLUGGED IN AND CHARGING WHEN THE CUSTOMER NOTICIED BLACK SMOKE AND THE END OF THE POWERCORD TURNED BLACK. NO INJURIES REPORTED BY THE CUSTOMER. THE CONSUMER STATED THEY WERE TO BE CONTACTING AN ELECTRICIAN TO DETERMINE THE SOURCE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058287 PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP ADVANCED POWERED BREAST PUMP HGX PHILIPS CONSUMER LIFESTYLE B.V. SCF394/61

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other