BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 10063464 · Received May 15, 2020

    Report

    Report Number
    3010617000-2020-00499
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Date of Event
    April 27, 2020
    Report Date
    May 15, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMOGARD IVTM CONSOLE (SN: (B)(4)) WAS EVALUATED BY ZOLL SERVICE AT THE CUSTOMER SITE. THE CUSTOMER REPORTED COMPLAINT OF "THE THERMOGARD XP IVTM SYSTEM (SN: (B)(4)) DISPLAYED TCMID:02 (CE DANFOSS ERROR) ERROR MESSAGE" WAS CONFIRMED BASED ON THE EVENT LOG REVIEW AND DURING FUNCTIONAL TESTING. THE ROOT CAUSE WAS DUE TO POOR CABLE CONNECTION BETWEEN DANFOSS MODULE (CE) AND PIC 16 BOARD DUE TO A BURNT PIN ON ONE OF THE CONNECTORS, AS A RESULT OF OVER-TIME ACCUMULATION OF DIRT AND MOISTURE INSIDE THE PINS OF THE CONNECTORS. THE THERMOGARD CONSOLE IS A REUSABLE DEVICE AND WAS MANUFACTURED IN SEPTEMBER 2015, AND IT IS ALMOST 5 YEARS OLD, APPROACHING ITS EXPECTED SERVICE LIFE OF 5 YEARS. DURING VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE IVTM THERMOGARD CONSOLE. REVIEW OF THE EVENT LOGS SHOWED OCCURRENCE OF TCMID:02 (CE DANFOSS ERROR) ERROR MESSAGE; THUS, CONFIRMING THE REPORTED COMPLAINT. THE SYSTEM FAILED INITIAL FUNCTIONAL TESTING DUE TO TCMID:02 ERROR MESSAGE, AND THEREFORE, THE REPORTED COMPLAINT WAS CONFIRMED. THE INVESTIGATION FININGS REVEALED POOR CONNECTION BETWEEN THE P22 CONNECTOR OF THE PIC-HSG CABLE AND THE J22 CONNECTOR ON THE COOLING ENGINE CABLE, WHICH CONNECT THE DANFOSS MODULE (CE) TO THE PIC 16 BOARD. ONE OF THE PINS ON THE P22 CONNECTOR WAS OBSERVED BURNT. THE MOST PROBABLE ROOT CAUSE WAS DUE TO DIRT AND MOISTURE DIFFUSING INTO THE SYSTEM AND CAUSING A SHORT CIRCUIT. THE ASSEMBLY WIRE HARNESS PIC 16 WAS REPLACED TO REMEDY THE ISSUE, AND THE WIRE HARNESS COOLING ENGINE WAS REPLACED AS A PRECAUTIONARY MEASURE TO PREVENT THE REOCCURRENCE OF A POSSIBLE CONNECTION ISSUE BETWEEN THE TWO CONNECTORS. 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 SIMILAR COMPLAINT REPORTED FOR THERMOGARD CONSOLE WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    DURING DEVICE SETUP, THE THERMOGARD XP IVTM SYSTEM (SN: (B)(4)) DISPLAYED TCMID:02 (CE DANFOSS ERROR) ERROR MESSAGE. THE CUSTOMER WAS UNABLE TO CLEAR THE ERROR MESSAGE. ANOTHER IVTM SYSTEM WAS USED TO INITIATE AND COMPLETE THE PATIENT TREATMENT. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525192 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1