BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6123457 · Received November 22, 2016

    Report

    Report Number
    3010617000-2016-00841
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 13, 2016
    Report Date
    January 31, 2017
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT OF THE REPORTED EVENT WAS CONFIRMED BASED ON THE VISUAL INSPECTION TEST OF THE THERMOGARD. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE DUE TO THE BLOWN FUSE (LEFT) THAT WAS SHORTED WHEN THE UNIT WAS POWERED ON. THE EXACT ROOT CAUSE WAS UNKNOWN BUT THE MOST PROBABLE CAUSE OF THE ISSUE WAS DUE TO THE LEFT FUSE WAS OUT OF PLACE AND BLEW OUT WHEN THE UNIT WAS POWERED ON. TO REMEDY THE ISSUE, THE LEFT FUSE WAS REPLACED AND ONCE COMPLETED, THE THERMOGARD PASSED THE FUNCTIONAL TEST WITH NO ISSUE OBSERVED. VISUAL INSPECTION FOUND THAT THE THERMOGARD GAP FROM THE ROLLER PUMP WAS WIDER THAN NORMAL. THE ROLLER PUMPS GAP WAS ADJUSTED TO BE WITHIN THE NORMAL RANGE (UNRELATED) TO THE REPORTED COMPLAINT TO PREVENT THE RE-OCCURRENCE OF THE PROBLEM. ONCE ADJUSTED, THE FUNCTIONAL TEST WAS PERFORMED AND THE THERMOGARD PASSED THE FINAL FUNCTIONAL TEST WITH NO ISSUE. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THERMOGARD WITH SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ZOLL HAS RECEIVED THE DEVICE FOR EVALUATION. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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 ON (B)(6) 2016 AT 17:00, A PATIENT WAS HOSPITALIZED FOR HEAD TRAUMA. THE REASON FOR THERAPEUTIC IVTM WAS FOR FEVER MANAGEMENT. ON THE NEXT DAY (B)(6) 2016 AT 9:00, THE CONSOLE WAS SWITCHED TO STANDBY MODE, AS THE PATIENT WAS SCHEDULED TO BE EXAMINED FOR FEW HOURS. WHEN THE PATIENT WAS RETURNED FROM THE EXAMINATION ROOM, THE STAFF PRESSED THE CONSOLE "RUN" BUTTON TO RESUME THERAPY, BUT THE CONSOLE DID NOT POWER ON. THE STAFF UNPLUGGED THE POWER CORD AND PLUGGED IT BACK BUT THE CONSOLE STILL DID NOT TURN ON. THE USE OF CONSOLE WAS TERMINATED AND USED THE ARCTICSUN TO COMPLETE THE THERAPY WITHOUT ANY HEALTH INJURY TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772012 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1