BEUDAMED
    FDA Adverse Event Summary report: N

    EVENFLO FEEDING, INC.

    MDR report key: 5522649 · Received March 24, 2016

    Report

    Report Number
    3009826814-0316-00001
    Date Received
    March 24, 2016
    Date of Event
    January 25, 2016
    Report Date
    March 17, 2016
    Manufacturer
    EVENFLO FEEDING, INC.
    Product Code
    HGX
    PMA / PMN Number
    K131153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENFLO REPRESENTATIVES PERFORMED A SITE INSPECTION WHERE THE FIRE OCCURRED IN LATE FEBRUARY 2016 WHICH PROVIDED THE INFORMATION NEEDED TO FILE THIS REPORT. AT THAT TIME, OTHER ELECTRICAL DEVICES WERE OBSERVED IN THE HOME WHICH COULD HAVE CAUSED AND/OR CONTRIBUTED TO THE FIRE. DUE TO THE OTHER PRODUCTS IMPLICATED, THE INSPECTION WAS POSTPONED UNTIL ALL PROPER PERSONS COULD BE PRESENT FOR THE INSPECTION. THE AC/DC ADAPTER FOR THIS EVENFLO PUMP IS A CLASS 2 CIRCUIT, AS DEFINED IN THE NATIONAL ELECTRIC CODE. THE ADAPTER HAS AN INTERNAL CIRCUIT TO PREVENT ANY OVERVOLTAGE OR OVERCURRENT FROM REACHING THE DC SIDE OF THE TRANSFORMER; THEREFORE, SUCH A CONDITION CANNOT LEAD TO HIGH CURRENT AND/OR VOLTAGE AT THE WIRES AS THE CIRCUIT OPENS. ACCORDINGLY, EVENFLO HAS NO REASON AT THIS TIME TO BELIEVE THAT THE PUMP'S ADAPTER CAUSED OR CONTRIBUTED TO THE HOUSE FIRE AND THIS REPORT IS FILED IN AN ABUNDANCE OF CAUTION ONLY. ONCE THE SECOND INSPECTION IS COMPLETED, EVENFLO WILL SUPPLEMENT THIS REPORT.

    Description of Event or Problem · 1

    EVENFLO RECEIVED NOTICE OF A HOME FIRE IN WHICH IT WAS ALLEGED BY THE CONSUMER'S INSURANCE COMPANY THAT AN EVENFLO ELECTRIC BREAST PUMP AND/OR ITS ADAPTER MAY HAVE CONTRIBUTED TO THE INCIDENT. NO ONE WAS INJURED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178512 EVENFLO FEEDING, INC. ADVANCED DOUBLE ELECTRIC BREAST PUMP HGX EVENFLO FEEDING, INC. 516XXXX

    Patients

    Seq Age Sex Outcome Treatment
    1