BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRITICOOL

    MDR report key: 3679072 · Received December 19, 2013

    Report

    Report Number
    9616800-2013-00001
    Event Type
    Other
    Date Received
    December 19, 2013
    Date of Event
    October 12, 2013
    Report Date
    December 10, 2013
    Manufacturer
    MTRE ADVANCED TECHNOLOGY LTD.
    Product Code
    DWJ
    PMA / PMN Number
    K083662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER MANUAL AND THE STEP BY STEP INSTRUCTIONS, ATTACHED TO THE CRITICOOL, PROVIDE CLEAR USE INSTRUCTION. FOLLOWING THESE INSTRUCTIONS PROVIDE OPTIMAL THERMOREGULATION OF THE BODY AROUND THE SET POINT. THE USER DID NOT FOLLOW THE RECOMMENDED INSTRUCTIONS AND HAS NOT RESPONDED TO THE ALARM MESSAGES IN THE CORRECT WAY. AT THE END OF (B)(6) 2013, AN MTRE REPRESENTATIVE JOINED THE NEXT CARDIAC CASE THAT REQUIRED HYPOTHERMIA, AND THE PROCEDURE WAS PERFORMED WITHOUT FAULT. ON (B)(6) 2013 FULL TRAINING AND EXPLANATION OF THE CRITICOOL CONTROL PHILOSOPHY WAS PROVIDED BY MTRE TO ALL THE PHYSICIANS (ABOUT 15) OF THE CARDIOLOGY DEPARTMENT. MTRE CONCLUDES THAT THE PROBLEM REPORTED ABOVE WAS CAUSED DUE TO THE OPERATION OF THE SYSTEM BY A NURSE THAT WAS NOT TRAINED. PAGE 1-2 OF THE USER MANUAL STATES: PRECAUTIONS, FOLLOW THE WARNING NOTES LISTED IN THE VARIOUS SECTIONS OF THIS MANUAL. ONLY TRAINED PERSONNEL, FAMILIAR WITH ALL SYSTEM OPERATING PROCEDURES AND CERTIFIED ONLY BY MTRE ADVANCED TECHNOLOGIES LTD. OR AUTHORIZED AGENTS OF MTRE ADVANCED TECHNOLOGIES LTD. ARE ALLOWED TO USE THE CRITICOOL SYSTEM. ALL HOSPITAL PERSONNEL USING THE CRITICOOL SYSTEM MUST COMPLETE THE CRITICOOL TRAINING PROGRAM. REF#: (B)(4).

    Description of Event or Problem · 1

    ON FRIDAY NIGHT, (B)(6) 2013, A CALL WAS RECEIVED FROM THE CARDIOLOGY DEPARTMENT OF (B)(6), TO MTRE'S REPRESENTATIVE AT 2AM, SAYING THAT A PT WAS COOLED BELOW THE SET POINT (33 DEGREES CELSIUS) TEMPERATURE TO 32.6 DEGREES CELSIUS, AND WAS CONTINUING TO COOL ALTHOUGH THEY TRIED TO REWARM HIM. OUR REPRESENTATIVE GUIDED THEM WHAT THEY SHOULD DO BUT AFTER A WHILE, THEY CLAIMED THE PT WASN'T WARMING UP AND THE SYSTEM CONTINUED TO COOL AND THEY HAD TO SHUT DOWN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667719 CRITICOOL THERMAL REGULATING SYSTEM DWJ MTRE ADVANCED TECHNOLOGY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 MILD HYPOTHERMIA