BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG

    MDR report key: 3032985 · Received April 1, 2013

    Report

    Report Number
    1419937-2013-00182
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN THE PRODUCT WERE UNSUCCESSFUL. CUSTOMER WAS TO CALL BACK TO GIVE ADD'L INFO, BUT NEVER DID. CUSTOMER STATED THAT SHE THOUGHT SHE OBSERVED A SPARK FROM THE EXPOSED WIRES ON HER TRANSFORMER. FLAMES OR SIGNS OF BURNING WERE NOT REPORTED, NOR WAS THERE A REPORT OF AN INJURY. AS OF THE DATE OF THIS REPORT, THE ORIGINAL PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED OR CORRECTED INFO, A FOLLOW UP WILL BE FILED AT THAT TIME. 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 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE POWER SUPPLY FOR HER BREAST PUMP THAT WAS PURCHASED IN (B)(6) OF 2010, HAD EXPOSED WIRES. NO REPORT OF AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132670 PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG HGX MEDELA, INC. PRIOR TO REV L 9207010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1