BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM #UNK)

    MDR report key: 3955272 · Received June 16, 2014

    Report

    Report Number
    1419937-2014-00505
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW POWER SUPPLY WAS SENT TO THE CUSTOMER. ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER TO GET ADD'L COMPLAINT INFO AND TO THE PRODUCT BACK ARE ONGOING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. SHOULD ADD'L INFO OF 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 ONGOING.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HER POWER CHARGER STARTED FALLING APART AND IT MADE A HUGE SPARKS AND GAVE ME A HUGE SHOCK!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352290 PUMP IN STYLE (ITEM #UNK) HGX MEDELA, INC. 57XXX/9207010 PRIOR TO REV L-1512

    Patients

    Seq Age Sex Outcome Treatment
    1