BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6186709 · Received December 19, 2016

    Report

    Report Number
    3010617000-2016-00918
    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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED.. 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 DURING PREVENTIVE MAINTENANCE, THE THERMOGARDS XP IVTM SYSTEM (S/N: (B)(4)) LEAKED IN THE COLDWELL WHERE THE TUBING FITTING JOINED TO THE COLDWELL. THERE WERE NO SYSTEM ALARMS NOTED. NO PATIENT INVOLVED WITH THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836677 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1