BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2142144 · Received May 26, 2011

    Report

    Report Number
    1419937-2011-00120
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THOUGH SHE SAW SMOKE AND SPARKING AND THOUGH SHE DIDN'T SEE A FIRE, THERE WERE BURN MARKS ON HER BED COMFORTER (THEY LOOKED LIKE CIGARETTE HOLES). SHE INDICATED THAT THERE WAS NO BREACH IN THE TRANSFORMER HOUSING AND THERE WERE NO EXPOSED WIRES, BUT THE "COATING" APPEARS MELTED. SHE ALSO INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE AND THAT SHE WOULD RETURN THE POWER SUPPLY. AS OF THE DATE OF THIS REPORT, THE POWER SUPPLY HAS NOT BEEN RECEIVED. SPARKING IS INDICATIVE OF AT LEAST ONE SHORT IN THE DC CORD. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE CORD FOR THE POWER SUPPLY FOR HER PUMP IS SMOKING AND NOT WORKING. NO INJURIES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1