BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)

    MDR report key: 7002667 · Received November 6, 2017

    Report

    Report Number
    1419937-2017-00306
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    August 2, 2017
    Report Date
    November 4, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. THE CUSTOMER RETURNED THE POWER ADAPTER FOR EVALUATION. THE PRODUCT EVALUATION FOUND THE POWER SUPPLY HOUSING TO BE BREACHED. 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 FELL ON THE FLOOR AND PARTS OF THE HOUSING CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783975 ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK) PUMP, BREAST, POWERED HGX MEDELA LLC 57018W 9207010 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1