BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2102943 · Received May 12, 2011

    Report

    Report Number
    1419937-2011-00105
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN A F/U WITH THE CUSTOMER, SHE INDICATED THAT THE POWER SUPPLY "SPARKED BLUE SPARKS AND STARTED MAKING CRACKING SOUNDS" WHERE THERE ARE EXPOSED WIRES AT THE STRAIN RELIEF, THOUGH THERE WAS NO FIRE OR BREACH IN THE TRANSFORMER HOUSING. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE AND THAT SHE DISPOSED OF THE POWER SUPPLY. SPARKING IS INDICATIVE OF AT LEAST ONE SHORT IN THE DC CORD. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR EVAL/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. 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 4/4/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER PUMP HAS TWISTED AND EXPOSED WIRES THAT STARTED TO SPARK. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1