BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3972855 · Received April 28, 2014

    Report

    Report Number
    1419937-2014-00391
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER AND REQUEST THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVAL. IN F/U WITH THE CUSTOMER, SHE INDICATED THAT SHE DID GET A SMALL SHOCK FROM THE EXPOSED WIRES, HOWEVER, THERE WAS NO MEDICAL TREATMENT INVOLVED. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THE CUSTOMER REPORTED SPARKING FROM EXPOSED WIRES ON HER PUMP IN STYLE POWER ADAPTER. ON 04/04/2011, 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 DEGRADATION OF THE INSULATION SEPARATING THE POSITIVE AND NEGATIVE WIRES. THE PROBABLE CAUSES 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, CUSTOMERS 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 UPGRADED 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 CA (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 MGMT FOR INVESTIGATION/CAPA CONSIDERATION.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THAT HER TRANSFORMER HAD EXPOSED WIRES ON CORD AND SHE SAW SPARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253627 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/207010 PRIOR TO REV L-1115A

    Patients

    Seq Age Sex Outcome Treatment
    1