BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2062548 · Received March 21, 2011

    Report

    Report Number
    1419937-2011-00032
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 19, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE SAW SPARKING AT THE STRAIN RELIEF WHERE WIRES ARE EXPOSED, BUT DID NOT SEE A FIRE, SMOKING, MELTING OR A BREACH IN THE TRANSFORMER HOUSING. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. IN SUMMARY, A BREACH IN THE OUTER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT, EXPOSING WIRES, AND RESULTED IN A SHORT CIRCUIT WHICH CAUSED THE CORD TO HEAT UP AND SPARK. SPARKING POSES A RISK SHOULD IT COME IN CONTACT WITH A COMBUSTIBLE MATERIAL. CAPA (B)(4), APPROVED ON 11/18/2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/ MELTING ISSUES. ANY ADDITIONAL F/U ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS. EVAL SUMMARY. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED NO DEFORMATION ON THE TRANSFORMER HOUSING AND NO HOLES OR OPENINGS. A VISUAL EXAMINATION OF THE CORD REVEALED A BREACH OF BOTH THE POSITIVE AND NEGATIVE WIRES, WITH ABOUT ONE-HALF OF THE COPPER WIRES ON THE POSITIVE SIDE BROKEN. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.3 VDC, WHICH INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 1.2 OHMS, WHICH INDICATES THAT THERE IS 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 AT 58.8 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "A WEEK AGO [SHE] STARTED NOTICING SPARKING ON THE POWER CORD" FOR HER PUMP AND THAT THERE ARE EXPOSED WIRES. THE POWER CORD IS NOW NO LONGER WORKING, PER THE CUSTOMER. THE CUSTOMER DID NOT REPORT AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1