BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 2835347 · Received November 5, 2012

    Report

    Report Number
    1419937-2012-00696
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT POWER SUPPLY FOR HER BREAST PUMP. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THE HOUSING HAD CRACKED THE FIRST TIME SHE UNPLUGGED IT AND CONTINUED TO CRACK UNTIL IT FELL APART. CUSTOMER ALSO STATED THERE WAS NO SPARK, FIRE, OR FLAME. CUSTOMER INDICATED THAT SHE HAD SENT THE POWER SUPPLY BACK TO MEDELA, INC FOR EVALUATION/ANALYSIS. THE PRODUCT INVOLVED IN THE COMPLAINT HAS NOT BEEN RECEIVED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THE CUSTOMER DID E-MAIL A PICTURE OF THE POWER SUPPLY WHICH IS ATTACHED ON PAGE THREE. THE PICTURE CONFIRMS THE BREACH IN THE TRANSFORMER HOUSING. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. THIS TYPE OF FAILURE 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 CA10-049 WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON (B)(4) 2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT WHEN SHE UNPLUGGED HER POWER SUPPLY FOR HER BREAST PUMP FROM THE WALL, THE POWER SUPPLY CRACKED AND HAS BEEN BREAKING MORE SINCE. CUSTOMER INDICATED THAT SHE CANNOT UNPLUG THE POWER SUPPLY FROM THE WALL BECAUSE THE POWER SUPPLY WILL FALL APART COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. 57XXX/9207010 REV L 2011

    Patients

    Seq Age Sex Outcome Treatment
    1