BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2051244 · Received April 6, 2011

    Report

    Report Number
    1419937-2011-00060
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE FIRE OR SMOKE AND THAT THERE IS NO BREACH IN THE TRANSFORMER HOUSING, BUT SHE DID SEE SPARKING. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. IN SUMMARY, A BREACH IN THE INSULATION OF BOTH THE POSITIVE AND NEGATIVE WIRES ON THE DC OUTPUT CORD AT THE STRAIN RELIEF WERE PRESENT AND COULD CAUSE SPARKING IF BOTH WIRES WERE TO TOUCH. AS A RESULT OF (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON (B)(4) 2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. 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 IN THE INSULATION OF BOTH THE POSITIVE AND NEGATIVE WIRES AT THE STRAIN RELIEF. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.0 VDC, WHICH INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.7 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 INDICATES THAT THE THERMAL FUSE DID BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP HAS "WIRE COMING OUT OF THE TRANSFORMER." NO INJURIES WERE REPORTED.

    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