BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADVANCED PERSONAL DOUBLE

    MDR report key: 3874186 · Received April 23, 2014

    Report

    Report Number
    1419937-2014-00378
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED LOOSE PRONGS. SHE DID NOT REPORT OF ANY FIRE, SPARK OR INJURY. UPON RECEIPT OF THE TRANSFORMER, A BREACH WAS FOUND EXPOSING UNDERLYING ELECTRONICS. 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). EVALUATION 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 EXPOSED WIRES. THE TECHNICIAN WAS UNABLE TO TEST POWER SUPPLY VOLTAGE DUE TO EXPOSED WIRES ON CORD. 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 55.70 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE PRONGS ON THE TRANSFORMER OF HER PUMP IN STYLE BREAST PUMP WERE LOOSE AND KEPT PUSHING IN. HOWEVER, WHEN THE PRODUCT WAS RECEIVED AND EVALUATED BY QE A BREACH IN THE TRANSFORMER WAS FOUND EXPOSING THE UNDERLYING ELECTRONICS WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245043 BP ADVANCED PERSONAL DOUBLE HGX MEDELA, INC. 9207010/57065 1313/REV N

    Patients

    Seq Age Sex Outcome Treatment
    1