BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 3853650 · Received April 3, 2014

    Report

    Report Number
    1419937-2014-00335
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. UPON RECEIPT OF THE PRODUCT AND THE QE EVAL, A BREACH IN THE TRANSFORMER WAS FOUND. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED 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 13.80 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 54.7 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE WAS HAVING LOW MILK EXPRESSION. UPON RECEIPT AND EVAL OF THE RETURNED PRODUCT, A BREACH WAS FOUND IN THE TRANSFORMER HOUSING EXPOSING UNDERLYING ELECTRONICS WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203295 BP ADVANCED PERSONAL DOUBLE HGX MEDELA, INC 9207010/57065 1413/REV N

    Patients

    Seq Age Sex Outcome Treatment
    1