BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2102077 · Received April 14, 2011

    Report

    Report Number
    1419937-2011-00078
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL COMPLAINT INFORMATION, BUT ALL WERE UNSUCCESSFUL. THE CUSTOMER DID, HOWEVER, RETURN THE POWER SUPPLY. EVALUATION SUMMARY, FOR DETAILS OF THE ANALYSIS/EVALUATION PERFORMED ON THE POWER SUPPLY. IN SUMMARY, A SHORT CIRCUIT CAUSED THE TRANSFORMER TO HEAT UP, RESULTING IN A BREACH IN THE HOUSING. A BREACH IN THE TRANSFORMER HOUSING IS A SAFETY RISK. AS A RESULT OF CAPA (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 DEFORMATION ON THE TRANSFORMER HOUSING WITH A HOLE APPROXIMATELY 1.25MM IN DIAMETER PRIMARILY FILLED WITH AN EXPOSED WIRE LEAD. A VISUAL EXAMINATION OF THE CORD REVEALED NO UNUSUAL FINDINGS. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.0 VDC, WHICH IS NOT NORMAL AND INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.4 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 TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER PUMP WAS HOT AND HAD MELTED AND WOULD NO LONGER POWER 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 57018W

    Patients

    Seq Age Sex Outcome Treatment
    1