BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD XP IVTM SYSTEM

    MDR report key: 6068360 · Received October 31, 2016

    Report

    Report Number
    3010617000-2016-00783
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 7, 2016
    Report Date
    December 30, 2016
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMOGARD XP IV SYSTEM WITH SERIAL NUMBER (B)(4) WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. THE REPORTED COMPLAINT OF THERMOGARD DISPLAYING ERROR MESSAGE TCMID: 02 WAS CONFIRMED DURING EVENT LOG REVIEW AND FUNCTIONAL TESTING. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS RELATED TO THE FAULTY MODULE DANFOSS CONTROLLER AND ASSEMBLY (B)(6). THE REPORTED TCMID: 02 (CE POST FAILURE) OCCURRED DURING FUNCTIONAL TESTING; THUS CONFIRMING THE REPORTED COMPLAINT. FURTHER INVESTIGATION DETERMINED THAT THE MODULE DANFOSS CONTROLLER AND ASSEMBLY PIC-HSG WERE FOUND TO BE FAULTY. THE MODULE DANFOSS CONTROLLER AND ASSEMBLY (B)(6) WERE REPLACED TO REMEDY THE TCMID: 02 ERROR MESSAGE. UNRELATED TO THE REPORTED COMPLAINT, THE SYSTEM'S TEMPERATURE FAILED DURING 14 DAY BURN-IN TESTING DUE TO A FAULTY COOLING ENGINE. A REVIEW OF THE EVENT LOG WAS PERFORMED AND FOUND SEVERAL TCMID: 02 (CE POST FAILURE) ERROR MESSAGES TO HAVE OCCURRED ON THE REPORTED EVENT DATE; THUS CONFIRMING THE REPORTED COMPLAINT. A VISUAL INSPECTION WAS PERFORMED AND FOUND THE COLD WELL GASKETS AND LID BUMPERS WERE DAMAGED AND THE ROTOR GAPS WERE WIDER. IN ADDITION, THE SEAL ROCKER SWITCH AND TOP LID HINGE SCREWS WERE MISSING. THE THERMOGARD XP IVTM SYSTEM IS A REUSABLE DEVICE AND WAS MANUFACTURED ON 2008. THEREFORE, THESE TYPE OF PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION IS CHARACTERISTIC OF NORMAL WEAR AND TEAR FOR THE LIFE OF THE SYSTEM. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THERMOGARD XP IV SYSTEM WITH SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERMOGARD XP IVTM SYSTEM (S/N: (B)(4)) WAS DISPLAYING TCMID:02(CE DANFOSS ERROR) ERROR DURING SETUP. ANOTHER SYSTEM WAS USED TO CONTINUE AND COMPLETE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718923 THERMOGARD XP IVTM SYSTEM THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1