BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6126282 · Received November 23, 2016

    Report

    Report Number
    3010617000-2016-00846
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 3, 2016
    Report Date
    December 30, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOLGARD (S/N (B)(4)) DISPLAY HEAD WAS RETURNED TO ZOLL FOR EVALUATION AND THE REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING. LOW BATTER VOLTAGE WAS IDENTIFIED AS THE ROOT CAUSE FOR MID: 26 (LOW BATTERY) ERROR MESSAGE. DURING FUNCTIONAL TESTING THE DISPLAY HEAD WAS OPENED AND THE BATTERY VOLTAGE WAS MEASURED. THE VOLTAGE MEASUREMENT WAS BELOW SPECIFICATION. THE DISPLAY HEAD WAS CLEANED TO REMEDY THE REPORTED COMPLAINT. EVENT DATA LOG WAS DOWNLOADED; HOWEVER THE EVENT LOG WAS EMPTY DUE TO LOW BATTERY VOLTAGE. AFTER THE DISPLAY HEAD WAS CLEANED, THE DEVICE PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE ZOLL CONSOLE IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COOLGARD 3000 IVTM SYSTEM (SN: (B)(4)) WAS DISPLAYING MID: 26 (LOW BATTERY) ERROR MESSAGE DURING SETTING UP THE SYSTEM. THE CUSTOMER USED ANOTHER SYSTEM TO CONTINUE AND COMPLETE THE TEMPERATURE MANAGEMENT THERAPY. THERE WERE NO REPORTS OF PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777184 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1