BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2062154 · Received March 17, 2011

    Report

    Report Number
    1419937-2011-00024
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER WERE MADE TO ACQUIRE ADD'L INFO RELATED TO THE COMPLAINT AND TO GET THE POWER SUPPLY BACK; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. AS OF THE DATE OF THIS REPORT, THE POWER SUPPLY HAS NOT BEEN RECEIVED. BASED ON INFO IN THE COMPLAINT, IT CANNOT BE CONFIRMED THAT THERE IS NOT A BREACH IN THE TRANSFORMER HOUSING. A BREACH IN THE TRANSFORMER HOUSING IS A SAFETY RISK. 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 ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED. (B)(4), APPROVED ON (B)(6) 2010, HAS BEEN INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES. ANY ADD'L FOLLOW UP ACTIONS WILL BE ESTABLISHED AS A RESULT OF THE CAPA PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE "ADAPTER" FOR HER PUMP "IS CRACKED AND THE INSIDES HAVE BECOME EXPOSED."

    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