BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 10287491 · Received July 17, 2020

    Report

    Report Number
    3010617000-2020-00682
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 22, 2020
    Report Date
    September 26, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL CONSOLE EVALUATION WAS PERFORMED AZM SERVICE DEPOT AND DURING THE TESTING, THE CUSTOMER REPORTED COMPLAINT OF BLANK DISPLAY PANEL SCREEN AND A BEEPING TONE WAS CONFIRMED, HOWEVER, THE ISSUE WAS OBSERVED INTERMITTENTLY. THE DISPLAY HEAD WAS RETURNED TO ZOLL AND UPON EVALUATION, THE REPORTED ISSUE COULD NOT BE DUPLICATED DURING THE FUNCTIONAL TESTING. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS LIKELY DUE TO THE LOOSE CONNECTION OF UMBILICAL CABLE FROM PRINTED CIRCUIT ASSEMBLY (PCA) TO THE DISPLAY HEAD MONITOR. THE THERMOGARD CONSOLE WAS MANUFACTURED IN SEPTEMBER 2013 AND IS ALMOST 7 YEARS OLD, PAST THE EXPECTED SERVICE LIFE OF 5 YEARS. DURING THE VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE DISPLAY HEAD. THE EVENT LOG REVIEW DONE BY AZM SERVICE DEPOT SHOWED NO SIGNIFICANT DISCREPANCIES. THE DISPLAY HEAD WAS CONNECTED TO THE GOOD KNOWN IVTM THERMOGARD CONSOLE AND PASSED THE INITIAL FUNCTIONAL TESTING AND A 5 DAYS BURN-IN TEST WITH NO ISSUES. THERE WAS NO DEVICE MALFUNCTION ON THE DISPLAY HEAD MONITOR, AND THE MONITOR FUNCTIONED AS INTENDED. ALSO, THE CONSOLE SN (B)(6) WAS TESTED IN THE FIELD WITH ANOTHER DISPLAY HEAD AND PASSED FUNCTIONAL TESTING WITHOUT ANY ERROR OR FAULT.

    Additional Manufacturer Narrative · 0

    THE INITIAL CONSOLE EVALUATION WAS PERFORMED AZM SERVICE DEPOT AND DURING THE TESTING, THE CUSTOMER REPORTED COMPLAINT OF BLANK DISPLAY PANEL SCREEN AND A BEEPING TONE WAS CONFIRMED, HOWEVER, THE ISSUE WAS OBSERVED INTERMITTENTLY. THE DISPLAY HEAD WAS RETURNED TO ZOLL AND UPON EVALUATION, THE REPORTED ISSUE COULD NOT BE DUPLICATED DURING THE FUNCTIONAL TESTING. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS LIKELY DUE TO THE LOOSE CONNECTION OF UMBILICAL CABLE FROM PRINTED CIRCUIT ASSEMBLY (PCA) TO THE DISPLAY HEAD MONITOR. THE THERMOGARD CONSOLE WAS MANUFACTURED IN SEPTEMBER 2013 AND IS ALMOST 7 YEARS OLD, PAST THE EXPECTED SERVICE LIFE OF 5 YEARS. DURING THE VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE DISPLAY HEAD. THE EVENT LOG REVIEW DONE BY AZM SERVICE DEPOT SHOWED NO SIGNIFICANT DISCREPANCIES. THE DISPLAY HEAD WAS CONNECTED TO THE GOOD KNOWN IVTM THERMOGARD CONSOLE AND PASSED THE INITIAL FUNCTIONAL TESTING AND A 5 DAYS BURN-IN TEST WITH NO ISSUES. THERE WAS NO DEVICE MALFUNCTION ON THE DISPLAY HEAD MONITOR, AND THE MONITOR FUNCTIONED AS INTENDED. AS A PRECAUTIONARY MEASURE, THE LCD INVERTER IN THE DISPLAY HEAD WAS REPLACED. ALSO, THE CONSOLE SN (B)(6) WAS TESTED IN THE FIELD WITH ANOTHER DISPLAY HEAD AND PASSED FUNCTIONAL TESTING WITHOUT ANY ERROR OR FAULT.

    Additional Manufacturer Narrative · 1

    THE ZOLL HAS RECEIVED THE DEVICE FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING PREVENTIVE MAINTENANCE, THE THERMOGARD XP SYSTEM (SN (B)(4)) PRODUCED A BEEPING TONE AND A BLANK DISPLAY PANEL SCREEN UPON POWER ON. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751675 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1