BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM # UNK)

    MDR report key: 2801122 · Received October 17, 2012

    Report

    Report Number
    1419937-2012-00640
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 23, 2012
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN F/U WITH THE CUSTOMER, SHE INDICATED THAT THE TRANSFORMER HAD FALLEN APART AND THE UNDERLYING ELECTRONICS WERE EXPOSED. THE CUSTOMER ALSO INDICATED THAT SHE WOULD RETURN THE PRODUCT. HOWEVER, AS OF THE DATE OF THIS REPORT THE PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR TRANSFORMER FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE (ITEM # UNK) HGX MEDELA, INC. UNK/9207010 REV L - 1211

    Patients

    Seq Age Sex Outcome Treatment
    1