BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)

    MDR report key: 7472097 · Received April 30, 2018

    Report

    Report Number
    1419937-2018-00114
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 18, 2018
    Report Date
    April 30, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. 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 ON THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP CRACKED AND THE METAL PRONGS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317283 ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK) PUMP, BREAST, POWERED HGX MEDELA LLC 57018W 9207010 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1