BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2972155 · Received February 15, 2013

    Report

    Report Number
    1419937-2013-00103
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN F/U WITH THE CUSTOMER. IN F/U WITH THE CUSTOMER, THE CUSTOMER INDICATED THAT THE HOUSING FOR THEIR TRANSFORMER CAME APART, EXPOSING THE UNDERLYING ELECTRONICS. THE CUSTOMER ALSO STATED THAT SHE WOULD RETURN THE ORIGINAL PRODUCT. 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 F/U REPORT WILL BE FILED AT THAT TIME. THOUGH THE PRODUCT HAS NOT BEEN RECEIVED AND EVALUATED, THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT UNTO 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 (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOUSING ON THEIR PUMP IN STYLE TRANSFORMER WAS FALLING APART, EXPOSING THE UNDERLYING ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69496 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063 / 9207010 2011 / REV L

    Patients

    Seq Age Sex Outcome Treatment
    1