BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2152457 · Received June 22, 2011

    Report

    Report Number
    1419937-2011-00136
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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 SHE DID NOT SEE A FIRE, SMOKE OR SPARKING, BUT THAT THE TRANSFORMER HOUSING GOT HOT AND A HOLE MELTED INTO THE TRANSFORMER HOUSING. SHE INDICATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE, THAT HER REPLACEMENT POWER SUPPLY IS WORKING WITHOUT ISSUE AND THAT SHE WOULD RETURN THE ORIGINAL POWER SUPPLY. HOWEVER, AS OF THE DATE OF THIS REPORT, THE POWER SUPPLY HAS NOT BEEN RECEIVED. 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. 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 (B)(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 BECAME HOT, MELTED AND HAS A HOLE. 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