BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP - NEW

    MDR report key: 2031772 · Received March 21, 2011

    Report

    Report Number
    1310379-2011-00025
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    March 10, 2011
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER REPORTS WHEN CHARGING THE PUMP BATTERY, THE UNIT BEGAN SMOKING FROM THE BATTERY COMPARTMENT. THE PUMP WAS RECEIVED AT THE COVIDIEN SERVICE CENTER AND UPON EVALUATION, THE BATTERY DOOR WAS FOUND BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KANGAROO EPUMP - NEW FEEDING PUMP LZH COVIDIEN 382400 C1150025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK