BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 11051792 · Received December 21, 2020

    Report

    Report Number
    3010617000-2020-01281
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 29, 2020
    Report Date
    January 28, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PRELIMINARY INVESTIGATION WAS PERFORMED ON THE THERMOGARD XP CONSOLE (SN: (B)(6)) AT THE CUSTOMER'S FACILITY ON (B)(6) 2020. THE ZOLL TECHNICIAN OPENED THE SIDE PANEL TO CHECK THE HOLDER SENSORS AND CONFIRMED THE SENSOR ON THE LOWER SIDE OF THE AIR TRAP BLOCK ASSEMBLY WORKED INTERMITTENTLY. ZOLL AZM SERVICE DEPOT IN JAPAN PERFORMED A SUBSEQUENT INVESTIGATION ON DECEMBER 2, 2020. THE REPORTED COMPLAINT OF THE THERMOGARD XP IVTM SYSTEM NOT RECOGNIZING THE AIR TRAP CHAMBER WAS CONFIRMED DURING THE FUNCTIONAL TESTING IN JAPAN. DURING THE VISUAL INSPECTION PERFORMED AT THE AZM SERVICE DEPOT, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE IVTM THERMOGARD CONSOLE. THE EVENT LOG REVIEW SHOWED NO SIGNIFICANT DISCREPANCIES OR ERROR MESSAGES. DURING INVESTIGATION, IT WAS NOTED THAT THE ISSUE WAS INTERMITTENT, AND THEREFORE, THE AIR TRAP BLOCK ASSEMBLY WAS REPLACED AS A PREVENTIVE PRECAUTIONARY MEASURE TO PREVENT POSSIBLE SYSTEM FAILURE IN THE FUTURE. HOWEVER, THE REPLACEMENT AIR TRAP BLOCK ASSEMBLY ALSO DID NOT FUNCTION AS INTENDED. THE FUNCTIONAL TEST CONDUCTED BY THE SERVICE TEAM IN JAPAN FAILED AS THE THERMOGARD SYSTEM INTERMITTENTLY DID NOT RECOGNIZE THE REPLACEMENT AIR TRAP BLOCK ASSEMBLY. DURING INVESTIGATION, IT WAS NOTED THAT THE SENSORS THAT RESPOND TO THE PRESENCE OF THE AIR TRAP DID NOT LIGHT UP, AND THE TGXP SYSTEM DISPLAYED A RED CHECK AIR TRAP ERROR MESSAGE AFTER THE POWER-ON-SELF-TEST (POST). THE REPLACEMENT AIR TRAP BLOCK ASSEMBLY WAS INVESTIGATED AT AZM SERVICE DEPOT. TO TROUBLESHOOT, THE AIR TRAP CHAMBER WAS INSPECTED, AND THE RJ45 CABLE CONNECTING TO THE AIR TRAP BLOCK WAS REPLACED, BUT THE ISSUE WAS NOT RESOLVED. FURTHERMORE, THE REPLACEMENT AIR TRAP BLOCK WAS TESTED IN A KNOWN GOOD CONSOLE AND THE ISSUE WAS REPLICATED ONCE MORE AS THE AIR TRAP WAS NOT RECOGNIZED BY THE SYSTEM. THE DEFECTIVE AIR TRAP BLOCK ASSEMBLY IN THE TGXP CONSOLE WAS THEN REPLACED WITH ANOTHER AIR TRAP BLOCK ASSEMBLY TO REMEDY THE FAULT. THE ISSUE WAS NO LONGER REPLICATED, AND THE TGXP SYSTEM FUNCTIONED AS INTENDED. FOLLOWING SERVICE IN JAPAN, THE THERMOGARD CONSOLE PASSED ALL TESTS WITH NO ISSUES, AND READINGS WERE WITHIN THE SPECIFIED LIMITS. AZM SERVICE DEPOT SENT BOTH DEFECTIVE AIR TRAP BLOCK ASSEMBLIES TO ZOLL CIRCULATION IN SAN JOSE FOR AN IN-DEPTH EVALUATION. THE REPORTED COMPLAINT THAT "THE THERMOGARD SYSTEM DID NOT RECOGNIZE THE AIR TRAP" WAS RE-CONFIRMED ON JANUARY 5, 2021, AS THE ISSUE WAS INTERMITTENTLY REPRODUCED WITH THE FIRST AIR TRAP BLOCK ASSEMBLY DURING THE FUNCTIONAL TESTING PERFORMED AT ZOLL SAN JOSE. DURING THE VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED ON THE RETURNED AIR TRAP BLOCK ASSEMBLY. DURING THE FUNCTIONAL TESTING, THE SENSORS OF THE FIRST AIR TRAP ASSEMBLY WERE FUNCTIONING INTERMITTENTLY WHEN INSTALLED IN A KNOWN GOOD TGXP CONSOLE. THE LED LIGHT TURNED GREEN AT FIRST BUT WHEN ROTATED THE AIR TRAP CHAMBER, THE AIR TRAP SENSORS LED LIGHTS WERE TURNED OFF. FURTHER INVESTIGATION WAS PERFORMED BY MANUFACTURING, AND THE REPORTED COMPLAINT COULD NOT BE DUPLICATED. THE INTERMITTENCY MAY HAVE BEEN RELATED TO THE TEST EQUIPMENT BEING USED. AN IN-DEPTH EVALUATION WAS ALSO PERFORMED ON THE SECOND RETURNED AIR TRAP BLOCK ASSEMBLY AT ZOLL CIRCULATION IN SAN JOSE ON JANUARY 26, 2021. DURING VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE SECOND RETURNED AIR TRAP BLOCK ASSEMBLY. AFTER PLACING THE AIR TRAP ASSEMBLY INTO A KNOWN GOOD THERMOGARD CONSOLE, THE SYSTEM DISPLAYED A MID:09 (AIR TRAP ASSEMBLY) ERROR MESSAGE DURING THE FUNCTIONAL TESTING, UNRELATED TO THE REPORTED COMPLAINT. INVESTIGATION REVEALED THAT THE AIR DETECTION CIRCUITRY DID NOT FUNCTION AS INTENDED. IT IS SUSPECTED THAT THE SECOND AIR TRAP ASSEMBLY MAY HAVE OPENED OR SHORTED CIRCUITS ON THE AIR TRAP PCB (PRINTED CIRCUIT BOARD). HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THE THERMOGARD CONSOLE WITH SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF THE THERMOGARD XP IVTM SYSTEM (SN: (B)(4)) DID NOT RECOGNIZE THE AIR TRAP WAS CONFIRMED DURING THE FUNCTIONAL TESTING. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS THE DEFECTIVE AIR TRAP SENSOR BLOCK, AS A RESULT OF A DEFECTIVE COMPONENT. DURING VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE IVTM THERMOGARD CONSOLE. THE EVENT LOG REVIEW SHOWED NO SIGNIFICANT DISCREPANCIES. THE INITIAL FUNCTIONAL TEST FAILED AS THE THERMOGARD SYSTEM COULD NOT RECOGNIZE THE AIR TRAP; THUS, CONFIRMING THE REPORTED COMPLAINT. DURING INVESTIGATION, IT WAS NOTED THAT THE SENSORS THAT RESPOND TO THE INSTALLATION OF THE AIR TRAP DID NOT LIGHT UP, AND THE TGXP SYSTEM DISPLAYED A RED CHECK AIR TRAP ERROR MESSAGE AFTER THE SELF-TEST. THE DEFECTIVE AIR TRAP BLOCK ASSEMBLY WAS REPLACED TO REMEDY THE FAULT. FOLLOWING SERVICE, THE THERMOGARD CONSOLE PASSED ALL TESTS WITH NO ISSUES, AND 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 COMPLAINT REPORTED FOR THE THERMOGARD CONSOLE WITH SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    DURING DEVICE CHECK, THE THERMOGARD XP IVTM SYSTEM (SN: (B)(4)) DID NOT RECOGNIZE THE AIR TRAP AFTER THE AIR TRAP CHAMBER WAS INSERTED INTO THE AIR TRAP HOLDER. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510913 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1