BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 9079738 · Received September 17, 2019

    Report

    Report Number
    3010617000-2019-00838
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 25, 2019
    Report Date
    October 11, 2019
    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

    THERMOGARD SYSTEM WAS RECEIVED AT ZOLL SAN JOSE FOR FURTHER EVALUATION. THE REPORTED COMPLAINT OF FLICKERING DISPLAY SCREEN AND "M ID:05" (POST EXT RAM) ERROR MESSAGE ON THE THERMOGARD XP IVTM SYSTEM (SERIAL # (B)(4) WERE CONFIRMED DURING FUNCTIONAL TEST. THE ROOT CAUSE WAS DUE TO DAMAGED PROCESSOR PCA. THE PROCESSOR PCA WAS REPLACED TO REMEDY THE FLICKERING DISPLAY SCREEN AND "M ID:05" (POST EXT RAM). ARCHIVE COULD NOT BE RECOVERED AND REVIEW DUE TO DAMAGED PROCESSOR PCA. AFTER PART REPLACEMENT, THE SYSTEM WAS RE-EVALUATED AND PASSED ALL THE FUNCTIONAL TESTS WITHOUT ANY FAULT OR ERROR. THERMOGARD XP IVTM SYSTEM IS READY FOR IVTM THERAPY USE. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THERMOGARD XP IVTM SYSTEM WITH SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF FLICKERING DISPLAY SCREEN AND "M ID:05" (POST EXT RAM) ERROR MESSAGE ON THE THERMOGARD XP IVTM SYSTEM (SERIAL (B)(4)) WERE CONFIRMED DURING FUNCTIONAL TEST. THE ROOT CAUSE WAS DUE TO DAMAGED DISPLAY HEAD. DURING VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED ON THE CONSOLE. THE INITIAL FUNCTIONAL TESTING FAILED DUE TO FLICKERING SCREEN AND "M ID:05" (POST EXT RAM) ERROR MESSAGE. THERMOGARD SYSTEM WILL BE SENT TO ZOLL SAN JOSE FOR FURTHER EVALUATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THERMOGARD XP IVTM SYSTEM WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING WORKSHOP, THE DISPLAY SCREEN OF THERMOGARD XP IVTM SYSTEM (SERIAL (B)(4)) WAS FLICKERING. WHEN AZM TS SWITCHED THE DISPLAY HEAD WITH A KNOWN GOOD DISPLAY HEAD AT THE CUSTOMER SITE, NO PROBLEM OCCURRED. THEN, AZM TS BROUGHT BACK THE REMOVED SUSPECTED DISPLAY HEAD TO THE OFFICE AND ATTACHED TO ANOTHER TGXP CONSOLE (AZM'S DEVICE). THE REPORTED FLICKERING ISSUE OCCURRED AND "M ID:05" (POST EXT RAM) DISPLAYED ON THE SCREEN. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871079 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1