BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG

    MDR report key: 4843853 · Received June 12, 2015

    Report

    Report Number
    1419937-2015-00175
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER AND REQUESTED THE DEFECTIVE POWER ADAPTER BE RETURNED FOR EVALUATION. A PRODUCT EVALUATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF EXPOSED WIRES ON POWER CORD. A PRODUCT EVALUATION ALSO REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE IS BEING ASSESSED IN INVESTIGATION (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 04/04/2011. ACTIVITIES RELATED TO THIS NOTIFICATION ARE ON-GOING. A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS BREACHED, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED EXPOSED WIRES ON CORD. THE POWER SUPPLY WAS NOT PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS NOT MEASURED. RESISTANCE ACROSS THE DC PLUG WAS MEASURED AT 194 K OHMS, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. THE RESISTANCE ACROSS THE AC BLADES MEASURED AT 42.6 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTED TO MEDELA CUSTOMER SERVICE THAT HER PUMP IN STYLE POWER ADAPTER CORD WAS FRAYED BUT NO WIRES WERE SHOWING. DURING THE PRODUCT EVALUATION ON (B)(6) 2015, THE TECHNICIAN OBSERVED A BREACHED TRANSFORMER HOUSING, EXPOSING INNER ELECTRICAL CIRCUITRY, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384209 PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG HGX MEDELA, INC. 57026/207041 2704

    Patients

    Seq Age Sex Outcome Treatment
    1