BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ACTION ADVANCED BREAST PUMP FO TOTE

    MDR report key: 2982743 · Received February 25, 2013

    Report

    Report Number
    1419937-2013-00120
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, SHE INDICATED THAT AFTER APPROX 7 MONTHS OF USE, THE TRANSFORMER BACK CASING FELL OFF WHEN SHE UNPLUGGED IT FROM THE WALL BECAUSE THE SCREWS THAT HOLD IT TOGETHER CRACKED OFF EXPOSING INNER ELECTRONICS. THE CUSTOMER INDICATED THAT SHE DID NOT WITNESS ANY SPARKING, FIRE/FLAME, AND NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. 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. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW-UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER STATES HER TRANSFORMER FELL APART, THE SCREWS CAME OUT AND SHE CAN SEE THE INSIDES OF THE TRANSFORMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79408 PUMP IN STYLE ACTION ADVANCED BREAST PUMP FO TOTE HGX MEDELA, INC. 57063 / 9207010 REV L - 2011

    Patients

    Seq Age Sex Outcome Treatment
    1