BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO JOEY,PUMP W/POLE CLMP

    MDR report key: 5940298 · Received September 9, 2016

    Report

    Report Number
    3006451981-2016-00401
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Report Date
    January 13, 2025
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMIT DATE: 02/11/2017. AN EVALUATION WAS PERFORMED FOR KANGAROO JOEY PUMP FOR THE REPORTED CONDITION OF THE UNIT OVER/UNDER DELIVERING. THE UNIT WAS TRIAGED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THIS UNIT WAS MANUFACTURED IN 2011 AND WAS RELEASED MEETING ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    PER FDA REQUEST, THIS FOLLOW-UP REPORT WAS ELECTRONICALLY RESUBMITTED. ALL RELEVANT SUBSTANTIVE INFORMATION WAS PREVIOUSLY SUBMITTED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/07/2017. ON THE INITIAL 3500A, IT WAS REPORTED THAT THE INCIDENT FOR THIS REPORT WAS FOUND DURING SERVICE TRIAGE WHICH WAS INACCURATE. UPDATED TO REFLECT THE ACTUAL DESCRIPTION THE CUSTOMER REPORTED TO COVIDIEN ON (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 09/09/2016. 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) 2016 THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN ENTERAL FEEDING PUMP. THE CUSTOMER STATES THAT THE UNIT OVER/UNDER DELIVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN ENTERAL FEEDING PUMP. UPON TRIAGE, IT WAS FOUND THAT THE UNIT OVER/UNDER DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591926 KANGAROO JOEY,PUMP W/POLE CLMP ENTERAL FEEDING PUMP LZH COVIDIEN 383400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown