BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6163405 · Received December 9, 2016

    Report

    Report Number
    3010617000-2016-00876
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 9, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N # (B)(4) WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THERMOGARD XP IVTM SYSTEM S/N: (B)(4). VISUAL INSPECTION OF THE RETURNED CONSOLE SHOWED THAT THE COVER DECK XP AND FRONT COVER XP WERE BROKEN. ADDITIONALLY, THE WHITE ROLLERS AND LID PUMPERS WERE DAMAGED. PLUS THE GREEN LED (D1) ON THE COOLANT RESERVOIR SENSOR PRINTED CIRCUIT BOARD IS FAULTY. THE HALL SENSOR WIRES IN PUMP RACEWAY WERE NOT COVERED WITH GREASE. THE THERMOGARD CONSOLE IS A REUSABLE DEVICE AND WAS MANUFACTURED ON 04/13/2012. THEREFORE, THESE TYPE OF PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE CHARACTERISTIC OF NORMAL WEAR AND TEAR FOR THE LIFE OF THE DEVICE AND IS NOT RELATED TO THE REPORTED COMPLAINT. A REVIEW OF THE EVENT LOG WAS PERFORMED AND FOUND MULTIPLE MID: 01 (POST WATCHDOG) ERRORS TO HAVE OCCURRED ON THE REPORTED EVENT DATE; THUS CONFIRMING THE REPORTED COMPLAINT. ADDITIONALLY, THE MID: 14 (BG POWER SUPPLY) ERRORS WERE ALSO OBSERVED AND IT'S NOT RELATED TO THE REPORTED COMPLAINT. THE CONSOLE FAILED THE FUNCTIONAL TESTING. THE CONSOLE DISPLAYED MID: 01 AND MID 14 ERRORS UPON POWERING ON. FURTHER INVESTIGATION SHOWED THAT THE FAULTY POWER SUPPLY WAS CAUSING THE CONSOLE TO DISPLAY MID:01 AND MID:14 ERROR MESSAGES. IN ADDITION, THE COOLANT RESERVOIR SENSOR PRINTED CIRCUIT BOARD WAS ALSO REPLACED. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING EVENT LOG REVIEW AND FUNCTIONAL TESTING AND WAS ATTRIBUTED TO A FAULTY POWER SUPPLY. AFTER THE POWER SUPPLY AND DAMAGED PARTS WERE REPLACED, THE CONSOLE PASSED ALL FUNCTIONAL AND ELECTRICAL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERMORGARD IVTM SYSTEM (S/N: (B)(4)) DISPLAYED MID:01 (POST WATCHDOG) ERROR MESSAGE UPON POWERING UP. ANOTHER SYSTEM WAS USED TO TREAT PATIENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, WERE UNSUCCESSFUL. NO OTHER PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808843 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1