BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2063216 · Received March 22, 2011

    Report

    Report Number
    1419937-2011-00041
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    November 1, 2010
    Report Date
    March 17, 2011
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP AND POWER SUPPLY WERE SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE DID NOT SEE A FIRE, SMOKE, SPARKING OR ANY EXPOSED WIRES ON THE POWER SUPPLY CORD, BUT DID MELTING ON THE TRANSFORMER HOUSING "TO THE POINT THAT METAL WAS PROTRUDING THROUGH THE CASING." SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE AND THAT SHE DISPOSED OF THE POWER SUPPLY. A BREACH IN THE TRANSFORMER HOUSING POSES A SAFETY RISK. WITHOUT THE PRODUCT, AN ANALYSIS/EVAL CANNOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT THAT THERE IS A HOLE IN THE TRANSFORMER HOUSING CAN BE NEITHER REFUTED NOR SUBSTANTIATED AND THE CAUSE OF THE ISSUE CANNOT BE DETERMINED. A CONCLUSION CANNOT BE MADE. SHOULD ADD'L INFO BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4), APPROVED ON (B)(4) 2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADD'L F/U ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR HER PUMP "MELTED TO THE POINT THAT METAL WAS PROTRUDING THROUGH THE CASING." THE CUSTOMER DID NOT REPORT AN INJURY.

    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