BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK

    MDR report key: 6900305 · Received September 28, 2017

    Report

    Report Number
    1419937-2017-00269
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. THE PRODUCT WAS RECEIVED AND A BREACH IN THE HOUSING WAS CONFIRMED. 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) 2017, THE CUSTOMER REPORTED TO MEDELA LLC THAT THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP WAS HEAVY AND KEPT FALLING. SHE INDICATED THAT THE HOUSING IS NOW BROKEN AND THE WIRES ARE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679933 PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK PUMP, BREAST, POWERED HGX MEDELA LLC 57062 9207010/REV N - 3113

    Patients

    Seq Age Sex Outcome Treatment
    1