BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK

    MDR report key: 7832367 · Received August 30, 2018

    Report

    Report Number
    1419937-2018-00192
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 14, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WITH A DAMAGED REV N POWER SUPPLY FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4), WHICH WAS TRENDED AS PART OF THE EFFECTIVENESS CHECK FOR (B)(4), WHICH FOUND THAT THE POWER SUPPLIES WERE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. AS A PART OF ROUTINE CONTINUOUS IMPROVEMENT ACTIVITIES, THE REV N POWER SUPPLY WAS REPLACED WITH A REV P POWER SUPPLY, MANUFACTURED UNDER A REVISED DESIGN AND BY A DIFFERENT MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE HOUSING FOR HER PUMP IN STYLE POWER SUPPLY WAS DAMAGED - THE CASING HAD FALLEN APART AND WAS EXPOSING THE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672413 PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK PUMP, BREAST, POWERED HGX MEDELA LLC 57062 9207010 REV N 0813

    Patients

    Seq Age Sex Outcome Treatment
    1