BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 3874189 · Received April 23, 2014

    Report

    Report Number
    1419937-2014-00382
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVALUATION. THE PRODUCT EVALUATION CONFIRMED THE CUSTOMER REPORTED PROBLEM DAMAGED TRANSFORMER PRONG. THE PRODUCT EVALUATION ALSO REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED DAMAGED PRONGS AND THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 13.60 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE, AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 54.90 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER ADAPTER PRONG IS DAMAGED. DURING THE PRODUCT EVALUATION ON 04/08/2014, THE TECHNICIAN FOUND A BREACHED TRANSFORMER HOUSING WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245044 BP ADVANCED PERSONAL DOUBLE HGX MEDELA INC 57065/9207010 1413 REV N

    Patients

    Seq Age Sex Outcome Treatment
    1