BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6186449 · Received December 19, 2016

    Report

    Report Number
    3010617000-2016-00917
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 19, 2016
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A FAULTY AIR TRAP SENSOR. THE SYSTEM FAILED INITIAL FUNCTIONAL TESTING DUE TO THE AIR TRAP SENSOR WAS NOT DETECTED, THUS CONFIRMED THE REPORTED COMPLAINT. REPLACING THE AIR TRAP SENSOR REMEDIED THE REPORTED COMPLAINT. FOLLOWING SERVICE THE AIR FILTER WAS REPLACED AND PERFORMED YEARLY MAINTENANCE. THE ELECTRICAL SAFETY TEST WAS ALSO PERFORMED. THE SYSTEM PASSED FUNCTIONAL TESTING AND IT VERIFIED THAT THE SYSTEM MET ALL THE MANUFACTURING SPECIFICATIONS. NO ERRORS OR ANOMALIES WERE OBSERVED. A VISUAL INSPECTION WAS PERFORMED AND NO DISCREPANCIES WERE OBSERVED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRAINING, THE AIR TRAP SENSOR WAS NOT DETECTED WHEN THE AIR TRAP WAS REMOVED. THE SYSTEM DID NOT GENERATE THE ALARM OR STOP THE CIRCULATION PUMP AS IT SHOULD BE. THE REPORTED ISSUE OCCURRED DURING BOTH WARMING AND COOLING MODES. NO PATIENT INVOLVED WITH THIS EVENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837439 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR