BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 7620899 · Received June 20, 2018

    Report

    Report Number
    2183870-2018-00340
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Report Date
    October 2, 2018
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    UDI-DI
    10884521174818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TRIAGED AND THE CUSTOMER¿S REPORTED CONDITION WAS CONFIRMED. THE UNIT HAS BEEN REPAIRED. THE PUMP WAS EXCESSIVELY DAMA GED, SO THE ROOT CAUSE IS CATEGORIZED AS CUSTOMER MISUSE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THIS UNIT WAS MANUFACTURED AND WAS RELEASED MEETING ALL MANUFACTURING SPECIFICATIONS. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE UNIT WAS RETURNED FOR A BURN MARK ON THE INSIDE OF THE SCREEN. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465125 KANGAROO PUMP, INFUSION, ENTERAL LZH COVIDIEN 482400J 10884521174818

    Patients

    Seq Age Sex Outcome Treatment
    1