BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3021175 · Received March 21, 2013

    Report

    Report Number
    1419937-2013-00166
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. CUSTOMER WAS SENT A REPLACEMENT POWER CORD AND REQUESTED THE DEFECTIVE POWER CORD BE RETURNED FOR REPLACEMENT. THE DEFECTIVE POWER CORD HAS NOT BEEN RECEIVED AT MEDELA AS OF (B)(4) 2013. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. IN THE F/U WITH THE CUSTOMER, SHE INDICATED THAT THERE WAS A BREACH IN THE TRANSFORMER HOUSING. SHE PUMPS 1 TIME A DAY AND PLUGS IN/OUT THE TRANSFORMER ABOUT 1 TIME A DAY. SHE INDICATED THAT SHE DID NOT WITNESS ANY SPARKING, FIRE, OR FLAME AND THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. 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 (B)(4) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    CUSTOMER PLUGGED POWER ADAPTER INTO WALL AND THE TRANSFORMER HOUSING BROKE INTO PIECES AND THE INNER CIRCUITY OF THE POWER ADAPTER WERE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117165 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 9207010/57063 REV M

    Patients

    Seq Age Sex Outcome Treatment
    1