BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3180209 · Received June 13, 2013

    Report

    Report Number
    1419937-2013-00315
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER SHE STATED THAT THERE WAS NO HOLE IN TRANSFORMER HOUSING IT WAS JUST A MELTED SPOT. SHE ALSO INDICATED THAT SHE DID NOT WITNESS ANY SPARKING, FIRE OR FLAME AND THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. WHEN THE TRANSFORMER WAS RECEIVED BY MEDELA, IT HAD A SMALL HOLE MELTED IN THE CORNER OF THE TRANSFORMER HOUSING. AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS MALFUNCTION ARE ON-GOING. A VISUAL EXAM OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING HAD A MELTED HOLE, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAM OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 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 12 KILO OHMS, WHICH INDICATES THAT THERE IS NOT 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 AN OPEN CIRCUIT, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TRANSFORMER MELTED AND THERE WAS A HOLE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268076 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 17F

    Patients

    Seq Age Sex Outcome Treatment
    1