BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    MDR report key: 2854503 · Received November 29, 2012

    Report

    Report Number
    1419937-2012-00759
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 6, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. ATTEMPTS TO CONTACT THE CUSTOMER FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL. THE PRODUCT WAS RETURNED AND EVALUATED. A BREACH IN THE TRANSFORMER HOUSING WAS CONFIRMED. 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). AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUE. A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ONGOING. SHOULD ADDITIONAL INFO BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECT INFO, A FOLLOW UP REPORT WILL BE FILED. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED 0 VDC, WHICH IS NOT NORMAL AND INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 12 KILO OHMS, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS AN OPEN CIRCUIT, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID BLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2012 ,TO CUSTOMER SERVICE THAT HER POWER ADAPTER WAS NOT WORKING. UPON RECEIPT OF THE PRODUCT ON (B)(6) 2012, BY THE RETURNS DEPT, A BREACH IN THE HOUSING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK HGX MEDELA, INC. 57062/9207010 REV L - 1511

    Patients

    Seq Age Sex Outcome Treatment
    1