BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP - NEW

    MDR report key: 2960998 · Received January 15, 2013

    Report

    Report Number
    1717344-2013-00020
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 18, 2012
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER REPORTS THE BATTERY CAUGHT FIRE AND MELTED THE BATTERY DOOR. THE CUSTOMER STATES, PER INSPECTING THE UNIT, IT APPEARS THE WIRE CAUGHT FIRE. THE CUSTOMER REPORTS THE BATTERY DOOR AND JUST ABOVE THE BATTERY DOOR IS CHARRED BROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22173 KANGAROO EPUMP - NEW FEEDING PUMP LZH COVIDIEN 382400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1