BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATEMP

    MDR report key: 7650768 · Received June 29, 2018

    Report

    Report Number
    7650768
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 5, 2018
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BASIN FLUID WARMER SIDE POCKETS BECAME VERY HOT YET THE DIGITAL DISPLAY INDICATED 107 DEGREES F. THE TWO SIDE "BOTTLE POCKETS" ARE NOT TO EXCEED 110 DEGREES F. WE HAVE FOUND THAT THE BOTTLE TEMPERATURE CAN REACH 130 DEGREES F WHEN THE BOTTLE IS NOT RESTING OVER THE TEMPERATURE SENSOR. VARIOUS SIZE SOLUTION BOTTLES MAY BE PLACED INTO THESE POCKETS. THE SMALLER BOTTLES CAN BE PLACED IN THE POCKET SUCH THAT IT IS NOT RESTING OVER THE TEMPERATURE SENSOR. WHEN THE SENSOR IS NOT TOUCHING THE SIDE OF THE SOLUTION BOTTLE IT OVERHEATS THE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494676 INTRATEMP WARMER, IRRIGATION SOLUTION LHC MICROTEK MEDICAL, INC. ITW6L

    Patients

    Seq Age Sex Outcome Treatment
    1 4015 DA