BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP - NEW

    MDR report key: 1930552 · Received December 1, 2010

    Report

    Report Number
    1310379-2010-00023
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER STATED THAT THE PUMP IS DISPLAYING A SYSTEM ERROR. THE FEEDING PUMP WAS RECEIVED AT THE COVIDIEN SERVICE CENTER ON (B)(6) 2010. THE PUMP WAS EVALUATED ON (B)(6) 2010. UPON THE EVALUATION OF THE PUMP, THE TECHNICIAN REPORTED THAT THE UNIT HAD SCORCH MARKS ON THE AC CONNECTOR OF THE PCB BOARD AND BACK CASING. THE TECHNICIAN ALSO STATES THAT THERE IS NO EVIDENCE OF THESE SCORCH MARKS ON THE OUTSIDE OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KANGAROO EPUMP - NEW FEEDING PUMP LZH COVIDIEN 382400 C0515607

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK