BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2080448 · Received April 22, 2011

    Report

    Report Number
    1419937-2011-00090
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 INDICATED THAT SHE DID NOT SEE FIRE, SMOKE OR SPARKING AND THAT THERE WAS NO BREACH IN THE TRANSFORMER HOUSING BUT THERE WERE EXPOSED WIRES ON THE CORD. SHE ALSO INDICATED THAT HER PUMP QUIT WORKING AND WHEN SHE SENT TO UNPLUG THE POWER SUPPLY FROM THE WALL OUTLET, IT WAS HOT. SHE PLUGGED IT INTO A DIFFERENT OUTLET AND THE PUMP WORKED BUT THEN SHORTLY STOPPED WORKING. WHEN SHE UNPLUGGED IT FROM THAT OUTLET, HER FINGER TOUCHED UNDERNEATH THE TRANSFORMER HOUSING AND SHE GOT SHOCKED. SHE INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE ("NO MARKS ON FINGER OR ANYTHING") AND THAT SHE WOULD RETURN THE ORIGINAL POWER SUPPLY. IT CAN BE CONCLUDED THAT THE ISSUE WAS THE RESULT OF USER ERROR WHEREBY SHE TOUCHED THE METAL PRONGS WHILE REMOVING THE POWER SUPPLY FROM THE WALL OUTLET AND RECEIVED A SHOCK. SHOULD ADDITIONAL INFO OR ORIGINAL PRODUCT BE AVAILABLE FOR TESTING/ANALYSIS, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U 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 POWER SUPPLY FOR HER PUMP "GOT VERY WARM, GOT A SHOCK AT TOP OF PLUG, WIRES WERE EXPOSED." SHE INDICATED THAT HER PUMP WORKED FINE WITH THE BATTERY PACK.

    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