BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PJ COMFORT ELECTRIC BREAST PUMP

    MDR report key: 2616535 · Received June 8, 2012

    Report

    Report Number
    3002297831-2012-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    LIMERICK INC
    Product Code
    HGX
    PMA / PMN Number
    K051926
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: POWER CORD PROBLEM CAN BE RELATED TO THE OPERATOR'S USE AND TECHNIQUE OF BUNDLING THE POWER ADAPTER AND ELECTRICAL CORDS FOR CARRYING OR STORAGE. HOWEVER, CURRENT POWER CORD INSULATION IS ONLY UL/CSA SPT-1 RATED. DESIGN CONSIDERATIONS: ELECTRICAL CORD WITH SPT-2 INSULATION RATING WILL PROVIDE GREATER INSULATION THICKNESS TO MITIGATE THE RUPTURING OF ELECTRICAL CORDS. CHANGING TO POWER ADAPTERS THAT PLUG DIRECTLY INTO WALL OUTLETS (I.E. WITHOUT POWER CORD) SHOULD BE A CONSIDERATION.

    Description of Event or Problem · 1

    ELECTRICAL SHORT IN DEVICE POWER CORD, RESULTING IN ELECTRICAL SPARKING AND SINGEING CONSUMERS BLOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PJ COMFORT ELECTRIC BREAST PUMP BREAST PUMP HGX LIMERICK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening