BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 2852158 · Received November 12, 2012

    Report

    Report Number
    1419937-2012-00719
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT THE CUSTOMER A REPLACEMENT POWER ADAPTER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT ALL THREE OF THE SCREWS THAT HOLD THE TRANSFORMER HOUSING TOGETHER BROKE OR CRACKED AND EVENTUALLY THE ENTIRE HOUSING CAME APART TO THE POINT WHERE THE INSIDE WAS COMPLETELY EXPOSED. SHE DID NOT WITNESS ANY SPARKING, FIRE OR FLAME AND NO INJURIES WERE SUSTAINED AS A RESULT OF THE ISSUE. SHE ALSO INDICATED THAT SHE RETURNED THE POWER ADAPTER, HOWEVER, AS OF THE DATE OF THIS REPORT, IT HAS NOT BEEN RECEIVED. 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. SHOULD 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

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE AS FOLLOWS: "I HAVE BEEN USING MY BREAST PUMP FOR APPROXIMATELY A MONTH AND HALF BUT HAVE ALREADY RAN INTO AN ISSUE WITH YOUR PRODUCT. THE PUMP ITSELF WORKS FINE AND I DO FIND THAT ALL THE RECOMMENDATIONS I RECEIVED ON THIS PRODUCT FROM MY FAMILY WERE ACCURATE BUT I'VE ONLY USED THIS ITEM SINCE MY BABY WAS (B)(6) AND THE CASING ON THE ADAPTER TO SUPPLY POWER HAD CRACKED. NOW, I'M NOT SURE IF IT WAS LIKE THAT WHEN I RECEIVED IT BECAUSE THE CRACK WAS SMALL BUT NOW BECAUSE OF THE CRACK, IT MUST HAVE SPREAD FROM CONTINUOUS USE AND IT'S TO THE POINT WHERE THE WHOLE CASING ON THE POWER ADAPTER FELL APART. I CAN'T USE THE PRODUCT LIKE THIS AND I HAVE ONLY USED IT FOR A SHORT PERIOD OF TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. UNK/9207010 REV L - 2011

    Patients

    Seq Age Sex Outcome Treatment
    1