BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2852133 · Received November 12, 2012

    Report

    Report Number
    1419937-2012-00716
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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, THE CUSTOMER INDICATED THAT THEIR TRANSFORMER HAD FALLEN APART AND THEY UNDERLYING ELECTRONICS WERE EXPOSED. THE CUSTOMER ALSO INDICATED THAT SHE WOULD RETURN THE PRODUCT, HOWEVER, AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. THOUGH THE PRODUCT HAS NOT BEEN EVALUATED, THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT ONTO A HARD SURFACE OR OTHER TYPE OF SEVERE IMPACT. THE ORIGINAL DESIGN TESTING INVOLVED DROPPING THE UNIT FROM A 1.0 M HEIGHT PER UL2601-1 2ND EDITION. PRODUCTION SAMPLES WERE DROPPED THREE TO FIVE TIMES FROM A HEIGHT OF 1.0 M AND THE HOUSINGS SHOWED DAMAGE AND CRACKING (ONLY AFTER AT LEAST THREE DROPS). THIS PRODUCT WAS RELEASED AS A RESULT OF CAPA (B)(4), WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSFORMER FOR THEIR PUMP IN STYLE DEVICE WAS SPLIT IN HALF EXPOSING THE UNDERLYING ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV L

    Patients

    Seq Age Sex Outcome Treatment
    1