BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2080243 · Received April 7, 2011

    Report

    Report Number
    1419937-2011-00063
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. MULTIPLE ATTEMPTS THAT WERE MADE TO CONTACT THE CUSTOMER TO GET ADDITIONAL COMPLAINT INFORMATION WERE UNSUCCESSFUL. EVALUATION SUMMARY, FOR DETAILS OF THE ANALYSIS/EVALUATION PERFORMED ON THE POWER SUPPLY. IN SUMMARY, A BREACH IN THE OUTER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT AND RESULTED IN AN SHORT CIRCUIT WHICH COULD CAUSE SPARKING. 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. EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED NO DEFORMATIONS OF THE TRANSFORMER HOUSING AND BROKEN INSULATION EXPOSING WIRES ON THE DC OUTPUT CORD AT THE STRAIN RELIEF. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.6VDC, WHICH INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. NO SMOKE, FIRE, OR SPARKING WERE OBSERVED. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.75 OHMS, WHICH INDICATES THAT THERE IS A SHORT IN THE DC CORD. THE RESISTANCE CORD THE AC BLADES MEASURED AS 62.4 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP HAS EXPOSED WIRES AND IT SPARKED. IT NO LONGER POWERS HER PUMP. 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