BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUM PGO TOTE

    MDR report key: 4102228 · Received September 17, 2014

    Report

    Report Number
    1419937-2014-00712
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 12, 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 EVAL. THE DEFECTIVE POWER ADAPTER WAS RECEIVED AT MEDELA ON 0(B)(4) 2014 AND EVALUATED (B)(4) 2014. A PRODUCT EVAL CONFIRMED THE CUSTOMER REPORTED PROBLEM AND REVEALED THE TRANSFORMER HOUSING HAS A HOLE, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. 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)(4) 2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. EVAL SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING HAS A HOLE, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 0.0 VDC, WHICH IS NOT NORMAL AND INDICATES THAT THE POWER SUPPLY IS NOT PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE AC BLADES MEASURED OPEN, WHICH IS NOT NORMAL AND INDICATES THAT THE THERMAL FUSE HAD BLOWN. PICTURE #1 - CONDITION OF TRANSFORMER HOUSING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER REPORTED TO MEDELA CUSTOMER SERVICE THAT HER PUMP IN STYLE POWER ADAPTER HOUSING FELT HOT AND SMELLED OF BURNING PLASTIC. DURING THE PRODUCT EVAL ON (B)(4) 2014, THE TECH OBSERVED A MELTED HOLE IN THE TRANSFORMER HOUSING EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576213 PUMP IN STYLE ADVANCED BREAST PUM PGO TOTE HGX MEDELA, INC. 57063/9207010 13I PRIOR TO REV L

    Patients

    Seq Age Sex Outcome Treatment
    1