BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP LIBERTY RENTAL

    MDR report key: 7272585 · Received February 15, 2018

    Report

    Report Number
    1419937-2018-00046
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 14, 2018
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    PMA / PMN Number
    K142626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2018, THE CUSTOMER REPORTED THAT SHE WAS "PRETTY SURE YOU COULD SEE INSIDE THE POWER ADAPTER A LITTLE." THE ISSUE WITH THE LIBERTY DEVICE POWER SUPPLY HOUSING BREAKING OPEN WAS INVESTIGATED BY MEDELA (B)(4) UNDER (B)(4). THE INVESTIGATION IDENTIFIED THE ROOT CAUSE WAS WEAK WELDING OF THE POWER SUPPLY HOUSING. TWO CORRECTIVE ACTIONS RESULTED - IMPROVEMENT OF THE WELDING OF THE EXISTING POWER SUPPLY HOUSING, WHICH WAS IMPLEMENTED ON 07/30/2015 AND AN ALTERNATIVE POWER SUPPLY FROM A NEW SUPPLIER, WHICH HAS NOT YET BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE POWER SUPPLY FOR A LIBERTY PUMP WAS CRACKED FROM WEAR AND TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118114 PUMP LIBERTY RENTAL NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 08700/0770148

    Patients

    Seq Age Sex Outcome Treatment
    1