BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 7293644 · Received February 23, 2018

    Report

    Report Number
    3008361498-2018-00099
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VERIFIED THE TECHNICIAN¿S FINDING THAT THE UNIT POWERED ITSELF OFF TWICE IN BIOTECH MODE. THE UNIT WAS POWERED UP ON AND A LOW BATTERY MESSAGE WAS DISPLAYED. AC POWER WAS CONNECTED AND UNIT WAS OBSERVED TO CHARGE. THE UNIT WAS OBSERVED TO GO INTO THE VTBD MENU AND CYCLE THROUGH THE THOUSANDS VALUES. IT WAS FOUND THAT PRESSURE ON THE OVERLAY COULD BRIEFLY STOP THE CYCLING. THE OVERLAY WAS INSPECTED AND IT WAS FOUND THAT THE DOME ON SOFT KEY TWO WAS STUCK IN A PRESSED POSITION, CAUSING A BUTTON PRESS AND STUCK BUTTON EFFECT. THE UNIT WAS POWERED INTO BIOTECH MODE AND WAS OBSERVED TO TURN ITSELF OFF. PRESSING THE SECOND SOFT KEY IN BIOTECH MODE POWERS DOWN THE DEVICE. A TEST OVERLAY WAS CONNECTED. THE UNIT WAS POWERED INTO BIOTECH MODE. THE UNIT DID NOT POWER OFF. POWER CYCLED UNIT INTO OPERATION MODE. NO INVOLUNTARY KEY PRESSES WERE OBSERVED. THE LABEL ON THE OVERLAY SHOWS A DATE OF (B)(6)2013. THE UNIT HAS BEEN REPAIRED, AND RECERTIFIED PER PROCEDURE. THE UNIT WAS RESTORED TO PROPER OPERATION. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THE UNIT WAS SENT TO A SERVICE CENTER FOR REPAIR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE UNIT TO SERVICE WITH NO SPECIFIC ISSUE REPORTED. UPON TRIAGE ON (B)(6) 2018 THE SERVICE TECHNICIAN FOUND THAT THE UNIT POWERS DOWN ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136897 KANGAROO PUMP, INFUSION, ENTERAL LZH COVIDIEN 382401

    Patients

    Seq Age Sex Outcome Treatment
    1