BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP - NEW

    MDR report key: 3220683 · Received June 25, 2013

    Report

    Report Number
    3006451981-2013-00199
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Report Date
    June 3, 2013
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE 06/24/2013. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A KANGAROO E-PUMP. THE CUSTOMER STATED THAT THE BATTERY SHORTED IN THE UNIT AND CAUSED MELTING ON THE BATTERY DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287204 KANGAROO EPUMP - NEW E-PUMP LZH COVIDIEN 382400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK