BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3983361 · Received July 7, 2014

    Report

    Report Number
    1419937-2014-00544
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER TO GET ADD'L COMPLAINT INFO AND TO GET THE PRODUCT BACK ARE ONGOING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RETURNED. THE CUSTOMER REPORTED THAT HER TRANSFORMER WAS SPARKING AND THE CORD WAS SHREDDED ALMOST STARTING A FIRE WHICH IS A SAFETY RISK. ON (B)(4) 2011, MEDELA ISSUED A PUMP IN STYLE POWER ADAPTER SAFETY NOTIFICATION. THE SAFETY NOTIFICATION WAS THE RESULT OF THE FINDINGS OF CAPA (B)(4) WHICH ADDRESSED ISSUES WITH EXPOSED WIRES AND FOUND THE PROBABLE ROOT CAUSE TO BE A DEGRADATION OF THE INSULATION SEPARATING THE POSITIVE AND NEGATIVE WIRES. THE PROBABLE CAUSE OF THE DEGRADATION OF THE INSULATION HAVE BEEN ATTRIBUTED TO THE CORD BEING WRAPPED AROUND THE TRANSFORMER HOUSING AND/OR BEING PULLED FROM THE OUTLET BY THE CORD INSTEAD OF BY THE TRANSFORMER HOUSING. AS A RESULT, CUSTOMER WERE INFORMED NOT TO WRAP THE CORD AROUND THE TRANSFORMER TO PREVENT DAMAGE AND TO DISCONTINUE USE OF ANY TRANSFORMER THAT APPEARS DAMAGED. IN ADDITION, MEDELA HAS UPDATED THE CORD AND THE TRANSFORMER MATERIAL HAS BEEN CHANGED TO A MORE HEAT STABLE MATERIAL. THE UPDATED TRANSFORMER ALSO CONTAINS BOTH ELECTRICAL AND HEAT THERMAL FUSES SO THAT IN THE EVENT OF A FAILURE, THE TRANSFORMER WILL FAIL SAFE. THE SUBJECT UNIT WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION UNDER (B)(4). THE CUSTOMER WAS EITHER PROVIDED WITH A REPLACEMENT TRANSFORMER OR REFERRED TO AN ORDERING SOURCE TO RESOLVE THIS ISSUE. NO FURTHER ACTION IS REQUIRED. COMPLAINT DATA TRENDING WILL CONTINUE TO BE MONITORED BY MEDELA QUALITY MANAGEMENT FOR INVESTIGATION/CAPA CONSIDERATION. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECT INFO A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THAT SHE PLUGGED IN HER TRANSFORMER AND SPARKS WENT FLYING, THE CORD WAS SHREDDED AND ALMOST STARTED A FIRE IN MY KITCHEN, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394940 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 PRIOR TO REV I L17D

    Patients

    Seq Age Sex Outcome Treatment
    1