BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)

    MDR report key: 8418057 · Received March 13, 2019

    Report

    Report Number
    1419937-2019-00038
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    March 4, 2019
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451570181
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REFUSED TO RETURN THE POWER SUPPLY FOR TESTING/EVALUATION AND CUSTOMER SERVICE PROVIDED THE CUSTOMER WITH INFORMATION REGARDING HOW TO PURCHASE A REPLACEMENT POWER SUPPLY. 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) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP POWER SUPPLY HAD BROKEN APART DURING STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211407 ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK) PUMP, BREAST, POWERED HGX MEDELA LLC 57018W NA 00020451570181

    Patients

    Seq Age Sex Outcome Treatment
    1