BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED

    MDR report key: 2093361 · Received April 19, 2011

    Report

    Report Number
    1419937-2011-00086
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 A HOLE BURNED 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 EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A SUPPLEMENTAL 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 AND BURNED "HOLE IN BOX." SHE INDICATED THAT THE CORD HAS NO VISIBLE DAMAGE AND THAT SHE DOES WRAP THE CORD AROUND THE TRANSFORMER HOUSING WHEN STORING THE POWER SUPPLY. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED HGX MEDELA, INC. 57018W

    Patients

    Seq Age Sex Outcome Treatment
    1