BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 2062153 · Received March 17, 2011

    Report

    Report Number
    1419937-2011-00027
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT WIRES ARE EXPOSED ON THE CORD, SHE SAW SPARKING AT THE STRAIN RELIEF AS SHE WAS TAKING THE POWER SUPPLY OUT OF THE BAG TO GET READY TO PLUG IT IN, AND THAT THERE ARE NO SIGNS OF MELTING, BURNING OR FIRE. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE AND THAT HER REPLACEMENT POWER SUPPLY IS WORKING WITHOUT ISSUE. IN SUMMARY, A BREACH IN THE OUTER INSULATION OF THE CORD AT THE STRAIN RELIEF WAS PRESENT AND RESULTED IN AN SHORT CIRCUIT WHICH CAUSED THE CORD TO 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 ADD'L FOLLOW UP 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. A VISUAL EXAMINATION OF THE CORD REVEALED TWISTING (THE 6 FEET CORD WOULD ONLY HANG 1-2 FEET FROM THE TRANSFORMER) AND EXPOSED WIRES NEAR THE STRAIN RELIEF (ON THE DC SIDE, WHICH DOES NOT POSE AN ELECTROCUTION RISK). THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 12.1 VDC, WHICH INDICATES TAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 0.9 TO 0.7 OHMS, WHICH INDICATES THAT THERE IS AN INTERMITTENT SHORT IN THE DC CORD. SPARKING (FOR 1-2 SECONDS) WAS OBSERVED AFTER THE POWER SUPPLY WAS PLUGGED IN WHILE THE CORD WAS MOVING. THE RESISTANCE ACROSS THE AC BLADES MEASURED 60.6 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 "IS FRAYED AND WHEN IT WAS NOT PLUGGED IN, IT WAS THROWING SPARKS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1