BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE (ITEM #UNK)

    MDR report key: 3820814 · Received April 14, 2014

    Report

    Report Number
    1419937-2014-00361
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVALUATION. THE DEFECTIVE POWER ADAPTER HAS NOT BEEN RECEIVED AT MEDELA AS OF 04/09/2014. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. CUSTOMER FOLLOW UP WAS NOT SUCCESSFUL. 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. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS ASSESSED UNDER (B)(4). AS A RESULT OF CAPA (B)(4) WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES, A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON (B)(6) 2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE TRANSFORMER HOUSING HAS CRACKED OPEN EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228059 PUMP IN STYLE (ITEM #UNK) HGX MEDELA, INC. 57XXXX/9207010 3798K PRIOR TO REV L

    Patients

    Seq Age Sex Outcome Treatment
    1