BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2063217 · Received March 22, 2011

    Report

    Report Number
    1419937-2011-00043
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THERE WAS A BREACH IN THE TRANSFORMER HOUSING ("ON THE BACK LEFT CORNER, MELTED THROUGH"), BUT THAT SHE DID NOT SEE A FIRE, SMOKING, SPARKING, OR EXPOSED WIRES ON THE CORD. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. (B)(4). IN SUMMARY, A BREACH IN THE INNER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT, CAUSING A SHORT CIRCUIT AND THE TRANSFORMER TO HEAT UP, RESULTING IN A BREACH IN THE HOUSING. A BREACH IN THE TRANSFORMER HOUSING IS A SAFETY RISK. (B)(4), APPROVED ON (B)(4) 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. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED A DEFORMATION ON THE TRANSFORMER HOUSING AND AN APPROXIMATE 1.8MM DIAMETER HOLE WITH A WIRE LEAD STICKING OUT OF IT. A VISUAL EXAMINATION OF THE CORD REVEALED A KINK AT THE STRAIN RELIEF, BUT NO EXPOSED WIRES. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.00 VDC, WHICH INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.6 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 AS OPEN, WHICH IS NOT NORMAL AND INDICATES THAT THE THERMAL FUSE DID BLOW. THE OUTER INSULATION WAS CUT BACK AT THE STRAIN RELIEF TO REVEAL A BREAK IN THE INNER INSULATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE USING HER PUMP "THERE WAS A SMALL EXPLOSION AT THE BLACK BOX PORTION OF THE TRANSFORMER AND IT MELTED A HOLE RIGHT IN THE TRANSFORMER BOX. THE PUMP STILL WORKS." 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