BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRI-COOL II

    MDR report key: 3073018 · Received April 18, 2013

    Report

    Report Number
    3073018
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CINCINNATI SUB ZERO
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD COOLING PAD ON KNEE PER PROTOCOL AFTER A TOTAL KNEE REPLACEMENT. RN CARING FOR PATIENT IDENTIFIED THAT THE DEVICE WAS NOT COOLING. MACHINE WAS INSPECTED BY BIOMED. RANGE ON MACHINE IS SET FOR 5-7 DEGREES CELSIUS, HOWEVER WHEN MACHINE WAS TESTED IT WAS AT 15 DEGREES CELSIUS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TOTAL KNEE REPLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167923 ELECTRI-COOL II HYPOTHERMIA UNIT ILO CINCINNATI SUB ZERO 767 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *