BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 16656584 · Received March 31, 2023

    Report

    Report Number
    3010617000-2023-00311
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT "THE THERMOGARD XP IVTM SYSTEM (SERIAL #: (B)(4)) DISPLAYED "TCM ID:05" (COOLANT DIFF FAILURE) ERROR MESSAGE" WAS CONFIRMED IN THE CONSOLE'S EVENT LOG BUT NOT CONFIRMED DURING FUNCTIONAL TESTING. THE REPORTED TCM ID:05 ERROR MESSAGE WAS NOT REPLICATED DURING FUNCTIONAL TESTING. HOWEVER, THE ROOT CAUSE OF THE TCMID:05 ERROR WERE THE DEFECTIVE LM34 TEMPERATURE SENSOR AND I/O PCA, POSSIBLY DUE TO AGING OF THE DEVICE. THE THERMOGARD CONSOLE WAS MANUFACTURED IN JUNE 2014, IS OVER 8 YEARS OLD, AND HAS EXCEEDED ITS EXPECTED SERVICE LIFE OF 5 YEARS. DURING A VISUAL INSPECTION OF THE THERMOGARD CONSOLE, UNRELATED TO THE REPORTED COMPLAINT, NOTICED A CRACKED TOP LID WITH MISSING BUMPERS AND PRIME COVER, A CRACKED PUMP LID, COLD WELL ASSEMBLY ARE YELLOW AND DEGRADED, MISSING SCREW ON THE UMBILICAL CONNECTOR AND PAN DRIP, AND THE WHITE ROLLERS WERE WORN. THE PROBABLE CAUSE COULD BE DUE TO THE NORMAL WEAR AND TEAR OR COULD BE MISHANDLING. THE DAMAGED, MISSING AND WORN-OUT PARTS WERE REPLACED TO ADDRESS THE OBSERVED ISSUES. A REVIEW OF THE CONSOLE'S EVENT LOG REVEALED MULTIPLE TCMID:05 (COOLANT DIFF FAILURE) ERROR MESSAGES, THUS CONFIRMING THE REPORTED COMPLAINT. ALSO IN THE EVENT LOG, UNRELATED TO THE REPORTED COMPLAINT, MID:02 (TOO MANY COMMUNICATION TIME EVENTS), MID:20 (ADC1 TIMEOUT), MID:21 (ADC2 TIMEOUT), TC MID:07 (COOLANT TEMP HIGH) AND TC MID:08 (COOLANT TEMP LOW) ERRORS. THE ROOT CAUSE OF ALL THESE ERRORS ERROR WERE THE DEFECTIVE LM34 TEMPERATURE SENSOR AND I/O PCA, POSSIBLY DUE TO AGING OF THE DEVICE. THE THERMOGARD SYSTEM FAILED FUNCTIONAL TESTING AS THE CONSOLE DISPLAYED A TCMID:07 ERROR MESSAGE UPON POWERING UP, UNRELATED TO THE REPORTED COMPLAINT. THE TECHNICAL INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ERROR MESSAGE WAS DEFECTIVE LM34 TEMPERATURE SENSOR AND I/O PCA, AND WERE REPLACED TO REMEDY THE FAULT. FOLLOWING SERVICE, THE THERMOGARD CONSOLE PASSED ALL SUBSEQUENT FUNCTIONAL AND ELECTRICAL TESTS WITH NO ISSUES, AND ALL READINGS WERE WITHIN THE SPECIFIED LIMITS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE THERMOGARD CONSOLE WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 0

    DURING IVTM THERAPY, CUSTOMER REPORTED THAT THE THERMOGARD XP IVTM SYSTEM (SERIAL (B)(4)) DISPLAYED "TCM ID:05" (COOLANT DIFF FAILURE) ERROR MESSAGE. ANOTHER THERMOGARD CONSOLE WAS USED TO CONTINUE WITH TREATMENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623344 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown